Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study
Sponsor: Keri Pharma Hungary Kft • ClinicalTrials.gov ID: NCT07674446
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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.
Interventions
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Dimotec 1000 mg film-coated tablet
(Drug)
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.
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Detralex 1000 mg film-coated tablets
(Drug)
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.
Eligibility criteria
Conditions
Locations
- ClinSync Clinical Research Pvt. Ltd. — Hyderabad, India
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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