[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582132":3},{"organization":4,"outcomesModule":7,"designInfo":253,"detailedDescription":252,"studyPopulation":252,"armGroups":261,"interventions":278,"overallOfficials":252,"centralContacts":252,"locations":292,"responsibleParty":311,"collaborators":252,"id":313,"slug":252,"hasResults":314,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":252,"eligibilityCriteria":318,"healthyVolunteers":319,"sex":320,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":252,"studyType":326,"phases":327,"briefSummary":329,"conditions":330,"keywords":252,"overallStatus":295,"whyStopped":252,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Valenta Pharm JSC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":73,"otherOutcomes":252},[9,13,16,19,23,26,29,32,35,38,41,44,48,51,54,58,61,64,67,70],{"measure":10,"description":11,"timeFrame":12},"Pharmacokinetics - Cmax","Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below.","From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)",{"measure":14,"description":15,"timeFrame":12},"Pharmacokinetics - tmax","Time to reach Cmax (tmax)",{"measure":17,"description":18,"timeFrame":12},"Pharmacokinetics - AUC0-t","Area under the plasma concentration-time curve from time 0 to t (AUC0-t)",{"measure":20,"description":21,"timeFrame":22},"Pharmacokinetics - AUC0-inf","Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)","From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose",{"measure":24,"description":25,"timeFrame":22},"Pharmacokinetics - AUCextr","Extrapolated AUC defined as (AUC0-inf - AUC0-t)\u002FAUC0-inf",{"measure":27,"description":28,"timeFrame":12},"Pharmacokinetics - t1\u002F2","Elimination half-life (t1\u002F2)",{"measure":30,"description":31,"timeFrame":12},"Pharmacokinetics - kel","Elimination constant (kel)",{"measure":33,"description":34,"timeFrame":12},"Pharmacokinetics - MRT","Mean residence time (MRT)",{"measure":36,"description":37,"timeFrame":12},"Pharmacokinetics - Vd","Volume of distribution",{"measure":39,"description":40,"timeFrame":12},"Pharmacokinetics - CL","Clearance (CL)",{"measure":42,"description":43,"timeFrame":12},"Pharmacokinetics - number of terminal timepoints","Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant",{"measure":45,"description":46,"timeFrame":47},"Pharmacokinetics - AUC0-tau","Steady state area under the plasma concentration-time curve from time 0 to t (AUC0-tau)","From 0 to 48 hours (multiple dose)",{"measure":49,"description":50,"timeFrame":47},"Pharmacokinetics - Cmax,ss","Steady state maximum plasma concentration (Cmax,ss)",{"measure":52,"description":53,"timeFrame":47},"Pharmacokinetics - tmax,ss","Steady state time to reach Cmax,ss (tmax,ss)",{"measure":55,"description":56,"timeFrame":57},"Pharmacokinetics, urine - Aeinterval","The amount of active substance excreted in urine during each time interval (Aeinterval), calculated as the concentration in urine multiplied by the volume of urine.","From 48 to 72 hours (multiple dose)",{"measure":59,"description":60,"timeFrame":57},"Pharmacokinetics, urine - Ae(0-t)","Total urinary excretion from zero to time t (Ae(0-t)), calculated as the sum of the amounts excreted during each time interval",{"measure":62,"description":63,"timeFrame":57},"Pharmacokinetics, urine - Rmax","Maximum rate of urinary excretion (Rmax), calculated by dividing the amount of active substance excreted during each time interval by the time over which it was collected",{"measure":65,"description":66,"timeFrame":57},"Pharmacokinetics, urine - TRmax","Time of maximum urinary excretion (TRmax), calculated as the average time interval during which Rmax was observed",{"measure":68,"description":69,"timeFrame":57},"Pharmacokinetics, urine - Fe0-t","Fraction (% of dose) excreted from the body unchanged (Fe0-t), calculated as Ae\u002Forally administered dose",{"measure":71,"description":72,"timeFrame":57},"Pharmacokinetics, urine - CLR","Renal clearance (CLR), calculated as the ratio of Ae(0-t) to AUC(0-t)",[74,78,81,84,87,90,94,97,100,103,106,109,112,115,119,122,125,128,131,134,137,140,144,147,150,153,156,159,162,165,168,171,174,177,180,184,187,190,193,196,199,202,205,208,211,214,217,220,222,225,228,231,234,237,240,243,246,249],{"measure":75,"description":76,"timeFrame":77},"Adverse event type","Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.","From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)",{"measure":79,"description":80,"timeFrame":77},"Adverse event number","Number of adverse events registered during the study",{"measure":82,"description":83,"timeFrame":77},"Adverse event severety","Severity of adverse events registered during the study",{"measure":85,"description":86,"timeFrame":77},"Drop-outs associated with adverse events","The number of cases of early termination of participation in the study due to the development of adverse events and\u002For serious adverse events associated with the study drug",{"measure":88,"description":89,"timeFrame":77},"Safety and Tolerability: volunteer complaints","Description of any health-related complaints received from volunteer",{"measure":91,"description":92,"timeFrame":93},"Safety and Tolerability: physical examination results - cardiovascular system","An assessment of the condition of the cardiovascular system and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fcardiovascular symptoms, if any)","Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)",{"measure":95,"description":96,"timeFrame":93},"Safety and Tolerability: physical examination results - respiratory system","An assessment of the condition of the respiratory system and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Frespiratory symptoms, if any)",{"measure":98,"description":99,"timeFrame":93},"Safety and Tolerability: physical examination results - digestive tract","An assessment of the condition of the digestive tract and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fdigestive tract symptoms, if any)",{"measure":101,"description":102,"timeFrame":93},"Safety and Tolerability: physical examination results - endocrine system","An assessment of the condition of the endocrine system and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fendocrine symptoms, if any)",{"measure":104,"description":105,"timeFrame":93},"Safety and Tolerability: physical examination results - musculoskeletal system","An assessment of the condition of the musculoskeletal system and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fmusculoskeletal symptoms, if any)",{"measure":107,"description":108,"timeFrame":93},"Safety and Tolerability: physical examination results - nervous system","An assessment of the condition of the nervous system and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fneurological symptoms, if any)",{"measure":110,"description":111,"timeFrame":93},"Safety and Tolerability: physical examination results - sensory systems","An assessment of the condition of the sensory systems and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fsymptoms, if any",{"measure":113,"description":114,"timeFrame":93},"Safety and Tolerability: physical examination results - skin\u002Fvisible mucous membranes","An assessment of the condition of the skin\u002Fvisible mucous membranes and associated symptoms on physical examination (normal condition or a description of abnormal conditions\u002Fsymptoms, if any)",{"measure":116,"description":117,"timeFrame":118},"Safety and Tolerability: vital signs - systolic blood pressure","Systolic blood pressure (SBP, mmHg)","Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)",{"measure":120,"description":121,"timeFrame":118},"Safety and Tolerability: vital signs - diastolic blood pressure","Diastolic blood pressure (DBP, mmHg)",{"measure":123,"description":124,"timeFrame":118},"Safety and Tolerability: vital signs - heart rate","Heart rate (HR, bpm)",{"measure":126,"description":127,"timeFrame":118},"Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)","Body temperature (Celsius temperature scale)",{"measure":129,"description":130,"timeFrame":118},"Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate","12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)",{"measure":132,"description":133,"timeFrame":118},"Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval","12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)",{"measure":135,"description":136,"timeFrame":118},"Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex","12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)",{"measure":138,"description":139,"timeFrame":118},"Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval","12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave; Fredericia correction)",{"measure":141,"description":142,"timeFrame":143},"Safety and Tolerability: clinical blood test - hemoglobin","Hemoglobin (g\u002FL)","Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)",{"measure":145,"description":146,"timeFrame":143},"Safety and Tolerability: clinical blood test - hematocrit","Hematocrit (%)",{"measure":148,"description":149,"timeFrame":143},"Safety and Tolerability: clinical blood test - red blood cell count","Red blood cell count (cells\u002FL)",{"measure":151,"description":152,"timeFrame":143},"Safety and Tolerability: clinical blood test - platelet count","Platelet count (cells\u002FL)",{"measure":154,"description":155,"timeFrame":143},"Safety and Tolerability: clinical blood test - leukocyte count","Leukocyte count (cells\u002FL)",{"measure":157,"description":158,"timeFrame":143},"Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate","Erythrocyte sedimentation rate (mm\u002Fh)",{"measure":160,"description":161,"timeFrame":143},"Safety and Tolerability: clinical blood test - myelocytes","Leukocyte formula (myelocytes, %)",{"measure":163,"description":164,"timeFrame":143},"Safety and Tolerability: clinical blood test - band neutrophils","Leukocyte formula (band neutrophils, %)",{"measure":166,"description":167,"timeFrame":143},"Safety and Tolerability: clinical blood test - segmented neutrophils","Leukocyte formula (segmented neutrophils, %)",{"measure":169,"description":170,"timeFrame":143},"Safety and Tolerability: clinical blood test - eosinophils","Leukocyte formula (eosinophils, %)",{"measure":172,"description":173,"timeFrame":143},"Safety and Tolerability: clinical blood test - basophils","Leukocyte formula (basophils, %)",{"measure":175,"description":176,"timeFrame":143},"Safety and Tolerability: clinical blood test - monocytes","Leukocyte formula (monocytes, %)",{"measure":178,"description":179,"timeFrame":143},"Safety and Tolerability: clinical blood test - lymphocytes","Leukocyte formula (lymphocytes, %)",{"measure":181,"description":182,"timeFrame":183},"Safety and Tolerability: urinalysis - specific gravity","Specific gravity of the urine","Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)",{"measure":185,"description":186,"timeFrame":183},"Safety and Tolerability: urinalysis - color","Color of the urine",{"measure":188,"description":189,"timeFrame":183},"Safety and Tolerability: urinalysis - transparency","Transparency of the urine",{"measure":191,"description":192,"timeFrame":183},"Safety and Tolerability: urinalysis - pH","pH of the urine",{"measure":194,"description":195,"timeFrame":183},"Safety and Tolerability: urinalysis - protein","Protein concentration (g\u002FL)",{"measure":197,"description":198,"timeFrame":183},"Safety and Tolerability: urinalysis - glucose","Glucose concentration (mmol\u002FL)",{"measure":200,"description":201,"timeFrame":183},"Safety and Tolerability: urinalysis - red blood cells","Red blood cell content (number in sight)",{"measure":203,"description":204,"timeFrame":183},"Safety and Tolerability: urinalysis - white blood cells","White blood cell content (number in sight)",{"measure":206,"description":207,"timeFrame":183},"Safety and Tolerability: urinalysis - epithelial cells","Epithelial cell content (number in sight)",{"measure":209,"description":210,"timeFrame":183},"Safety and Tolerability: urinalysis - casts","Presence of casts (Yes\u002FNo)",{"measure":212,"description":213,"timeFrame":183},"Safety and Tolerability: urinalysis - mucus","Presence of mucus (Yes\u002FNo)",{"measure":215,"description":216,"timeFrame":183},"Safety and Tolerability: urinalysis - bacteria","Presence of bacteria (Yes\u002FNo)",{"measure":218,"description":219,"timeFrame":183},"Safety and Tolerability: urinalysis (microscopy)","Microscopy of urine sediment is performed if it is present",{"measure":221,"description":198,"timeFrame":93},"Safety and Tolerability: blood chemistry - glucose",{"measure":223,"description":224,"timeFrame":93},"Safety and Tolerability: blood chemistry - cholesterol","Total cholesterol concentration (mmol\u002FL)",{"measure":226,"description":227,"timeFrame":93},"Safety and Tolerability: blood chemistry - protein","Total protein concentration (g\u002FL)",{"measure":229,"description":230,"timeFrame":93},"Safety and Tolerability: blood chemistry - bilirubin","Total bilirubin concentration (micromol\u002FL)",{"measure":232,"description":233,"timeFrame":93},"Safety and Tolerability: blood chemistry - creatinine","Creatinine concentration (micromol\u002FL)",{"measure":235,"description":236,"timeFrame":93},"Safety and Tolerability: blood chemistry - alkaline phosphatase","Alkaline phosphatase activity (U\u002FL)",{"measure":238,"description":239,"timeFrame":93},"Safety and Tolerability: blood chemistry - alanine transaminase","Alanine transaminase activity (U\u002FL)",{"measure":241,"description":242,"timeFrame":93},"Safety and Tolerability: blood chemistry - aspartate transaminase","Aspartate transaminase activity (U\u002FL)",{"measure":244,"description":245,"timeFrame":93},"Safety and Tolerability: blood chemistry - potassium concentration","Potassium (mmol\u002FL)",{"measure":247,"description":248,"timeFrame":93},"Safety and Tolerability: blood chemistry - sodium concentration","Sodium concentration (mmol\u002FL)",{"measure":250,"description":251,"timeFrame":93},"Safety and Tolerability: blood chemistry - chloride concentration","Chloride concentration (mmol\u002FL)",null,{"allocation":254,"interventionModel":255,"interventionModelDescription":252,"primaryPurpose":256,"observationalModel":252,"timePerspective":252,"maskingInfo":257},"NON_RANDOMIZED","SEQUENTIAL","OTHER",{"masking":258,"maskingDescription":252,"whoMasked":259},"SINGLE",[260],"OUTCOMES_ASSESSOR",[262,268,273],{"label":263,"type":264,"description":265,"interventionNames":266},"Single and multiple doses, 90 mg + 5 mg","EXPERIMENTAL","Ingavirin Forte, 1 capsule (90 mg + 5 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 5 mg) taken twice a day for 2 days (the first dose under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.",[267],"Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 5 mg",{"label":269,"type":264,"description":270,"interventionNames":271},"Single and multiple doses, 90 mg + 10 mg","Ingavirin Forte, 1 capsule (90 mg + 10 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 10 mg) taken twice a day for 2 days (the first dose on an under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.",[272],"Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 10 mg",{"label":274,"type":264,"description":275,"interventionNames":276},"Single and multiple doses, 90 mg + 20 mg","Ingavirin Forte, 1 capsule (90 mg + 20 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 20 mg) taken twice a day for 2 days (the first dose under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.",[277],"Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 20 mg",[279,284,288],{"type":280,"name":281,"description":282,"armGroupLabels":283,"otherNames":252},"DRUG","Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 5 mg","Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 5 mg of N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid",[263],{"type":280,"name":285,"description":286,"armGroupLabels":287,"otherNames":252},"Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 10 mg","Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 10 mg of N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid",[269],{"type":280,"name":289,"description":290,"armGroupLabels":291,"otherNames":252},"Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 20 mg","Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 20 mg of N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid",[274],[293],{"facility":294,"status":295,"city":296,"state":252,"zip":252,"country":297,"countryCode":298,"cosmosGeoPoint":299,"geoPoint":304,"contacts":305},"State Budgetary Healthcare Institution of the City of Moscow \"City Clinical Hospital No. 15 named after O.M. Filatov of the Department of Health of Moscow.\"","RECRUITING","Moscow","Russia","RU",{"type":300,"coordinates":301},"Point",[302,303],37.61781,55.75204,{"lat":303,"lon":302},[306],{"name":307,"role":308,"phone":309,"phoneExt":252,"email":310},"Ivan Gordeev","CONTACT","+7495-918-72-84","cardio-15@yandex.ru",{"type":312,"investigatorFullName":252,"investigatorTitle":252,"investigatorAffiliation":252,"oldNameTitle":252,"oldOrganization":252},"SPONSOR","100582132",false,"NCT06859333","Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","An Open-label Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","Inclusion Criteria:\n\n1. Signed informed consent form by the healthy subject prior to any study activities.\n2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.\n3. Verified \"healthy\" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).\n4. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive).\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).\n7. Body temperature from 36.0°C to 36.9°C (inclusive).\n8. Body mass index (BMI): 18.5 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women.\n9. Agreement to use adequate contraceptive methods throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine pregnancy test result.\n\nNon-inclusion criteria:\n\n1. Known allergic history.\n2. Hypersensitivity to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug in the medical history.\n3. Drug intolerance to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug.\n4. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.\n5. Evidence or history of chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic and vision organs.\n6. History of GIT surgery (except for appendectomy at least 1 year prior to screening).\n7. Diseases\u002Fconditions that, in the judgment of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (SD).\n8. Acute infectious diseases less than 4 weeks before screening.\n9. Use of drugs that significantly affect hemodynamics, drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), drugs that prolong the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)), less than 2 months before screening.\n10. Regular use of drugs less than 2 weeks before screening and single use of drugs less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines).\n11. Blood or plasma donation within 3 months before screening.\n12. Use of hormonal contraceptives (in women) within 2 months before the start of screening.\n13. Use of depot injections of any drugs less than 3 months before the start of screening.\n14. Pregnancy or lactation; positive urine pregnancy test for women of childbearing potential.\n15. Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to taking study medications with an unsterilized partner.\n16. Participation in another clinical trial less than 3 months prior to screening or concurrently with this study.\n17. Consumption of more than 10 units of alcohol per week in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse.\n18. Smoking more than 10 cigarettes per day currently or having smoked that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during their stay at the research center.\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking the study drug.\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort within 7 days prior to taking the study drug.\n21. Dehydration due to diarrhea, vomiting or other causes within the last 24 hours before taking the study drug.\n22. Positive blood test to human immunodeficiency virus (HIV) types 1 and 2; antibodies to Treponema pallidum antigens; surface antigen of hepatitis B virus (HBsAg); antibodies to hepatitis C virus antigens at screening.\n23. Clinically significant deviations on electrocardiogram (ECG) in medical history and\u002For at screening including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women.\n24. Information on risk factors for developing torsades de pointes such as heart failure, hypokalemia, family history of prolonged QT syndrome.\n25. Positive urine test for narcotic substances and potent medications at screening.\n26. Positive test for alcohol vapors at screening.\n27. Planning hospitalization during the study period for any reason other than hospitalization provided for by this protocol.\n28. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, adhere to dietary and activity regimens.\n29. Belonging to a vulnerable group of volunteers: students from higher and secondary medical, pharmaceutical and dental educational institutions; junior staff from clinics and laboratories; employees of pharmaceutical companies; military personnel and prisoners; individuals in nursing homes; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or custody; individuals unable to give consent; as well as law enforcement officers.\n30. Other conditions that, in the judgment of the investigator, may interfere with participation in the study or may lead to early withdrawal of the volunteer including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or a special lifestyle (night work hours, extreme physical exertion).\n\nExclusion Criteria:\n\n1. The volunteer's withdrawal from further participation in the study.\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of prohibited medications, violation of dietary and lifestyle restrictions, etc.).\n3. The emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria.\n5. Development of a severe adverse event (SAE) and\u002For serious adverse reaction (SAR) in the volunteer during the study.\n6. The volunteer requires or undergoes treatment that may affect the pharmacokinetics of the study drug.\n7. Missing two or more consecutive blood samples or three or more blood samples during one study period.\n8. The occurrence of vomiting\u002Fdiarrhea within 8 hours after taking the study drug.\n9. Positive urine test for narcotic substances and potent medications.\n10. Positive test for alcohol vapors.\n11. Positive pregnancy test in female participants.\n12. The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.",true,"ALL","18 Years","45 Years",{"count":324,"type":325},36,"ESTIMATED","INTERVENTIONAL",[328],"PHASE1","This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.",[331,332],"Influenza","Viral Respiratory Infection","2025-07-02",{"date":335,"type":336},"2025-07-08","ACTUAL",{"date":338,"type":336},"2025-01-13",{"date":340,"type":325},"2025-12-31",{"name":5,"class":6},1]