Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-59
SponsorAJU Pharm Co., Ltd.
About this trial
To Evaluate the Safety and Pharmacokinetics of "AJU-C715" and "C715R" in Healthy Adults.
Eligibility criteria
Qualifiers
Healthy adults aged 19 to less than 60 years at the time of screening
Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
Those who are eligible for the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
Disqualifiers
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug. 3. Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
Those who are hypersensitive to component of the Investigational product and have the medical history
Those with active liver disease or persistent elevation of aminotransferase levels of unknown
Trial design
Treatments tested in this trial
- Test Drug
- Reference Drug
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
1H+ Yangji Hospital Seoul South Korea
Sponsors and collaborators
AJU Pharm Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov