Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

ConditionHealthy Volunteers

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorKeri Pharma Hungary Kft

About this trial

This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy adult human participants under fed conditions. The study will also evaluate the safety and tolerability of a single dose of the investigational products.

Eligibility criteria

Qualifiers

Healthy adult human participants aged 18 to 55 years (inclusive)

BMI between 18.50 and 30.00 kg/m2 (inclusive), capable of giving informed consent

Normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests during screening within 28 days of enrollment

Normal 12-lead electrocardiogram (ECG)

Disqualifiers

Contraindications or hypersensitivity to the study drug, related drug group, or excipients

History or presence of significant asthma, urticaria, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological, psychiatric, endocrine, immunological, hematopoietic, diarrheal, or ongoing infectious diseases, or any other significant abnormality

History or presence of gastrointestinal inflammation, bleeding, ulceration, hemorrhage, or perforation of the stomach, small intestine, or large intestine

History of dermatological diseases (skin reactions, skin rash) related to drug use, or presence of any dermatological diseases

Trial design

Treatments tested in this trial

Dimotec 1000 mg film-coated tablet
Detralex 1000 mg film-coated tablets

Treatment groups

72 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Keri Pharma Hungary Kft

Lead sponsor

Source ClinicalTrials.gov