Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

Recruiting Phase 1 Interventional Study
Healthy Volunteers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Keri Pharma Hungary Kft · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 serologic…
Contacts

Orsolya Gyurjan, PharmD

+36 52 502 610

info@keri.hu

CONTACT