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Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

NCT07674446 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Dimotec 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.

DRUG

Detralex 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.

Sponsors & Collaborators

  • Keri Pharma Hungary Kft

    lead INDUSTRY

Principal Investigators

  • Sharath Reddy A, MBBS · ClinSync Clinical Research Pvt. Ltd., Hyderabad, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2026-08-16
Completion
2026-12-29

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674446 on ClinicalTrials.gov