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 groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov