RecruitingPhase 1NCT07674446

Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

Comparative Bioavailability Study of Dimotec 1000 mg Film-coated Tablet Versus Detralex 1000 mg Film Coated Tablets in Healthy Subjects Under Fed Conditions: Randomized, Four-period, Full-replicate Crossover


Sponsor

Keri Pharma Hungary Kft

Enrollment

72 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Detralex 1000 mg film-coated tablets and a drug called Dimotec 1000 mg film-coated tablet for people with healthy volunteers. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDimotec 1000 mg film-coated tablet

Diosmin 1000 mg film-coated tablet. Single oral dose administered under fed conditions. Active substance: Diosmin 1000 mg. ATC code: C05CA03. Manufactured by MEDITOP Gyogyszeripari Kft., Hungary. Marketing Authorisation Holder: Keri Pharma Hungary Kft.

DRUGDetralex 1000 mg film-coated tablets

Diosmin 1000 mg film-coated tablets. Single oral dose administered under fed conditions. Active substance: Diosmin 1000 mg. ATC code: C05CA53. Manufactured by Servier (Ireland) Industries Ltd. Marketing Authorisation Holder: Les Laboratoires Servier Industrie, France.


Locations(1)

ClinSync Clinical Research Pvt. Ltd.

Hyderabad, India

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NCT07674446


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