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RECRUITING Phase 1 ClinicalTrials.gov

Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

Sponsor: Keri Pharma Hungary Kft • ClinicalTrials.gov ID: NCT07674446

Registry updated: 2026-09-09
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Description

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

  • 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.
  • 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

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 serological tests during screening within 28 days of enrollment * Normal 12-lead electrocardiogram (ECG) * Normal chest X-Ray (P/A view) taken not more than 180 days prior to check-in of Period 1 * Non-smoker or ex-smoker who stopped smoking at least 6 months before first dosing * Non-alcoholic * Female participants of childbearing potential must practice a medically acceptable method of contraception (double barrier, IUD, or abstinence); females with no childbearing potential defined as surgically sterile or post-menopausal for at least 1 year Exclusion Criteria: * 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 * Unable to swallow large-size tablets * Use of any food supplements containing flavonoids within 14 days before first dosing or during the study * Blood donation (500 mL) or participation in any clinical study within 90 days prior to check-in * Use of any prescribed medications, OTC medications, or herbal medications within 30 days prior to first dose * Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids, barbiturates) in urine at check-in * Positive urine/breath alcohol test at check-in * Positive pregnancy test * Currently pregnant, breast-feeding, or likely to become pregnant during the study * Use of implanted or injected hormonal contraceptives within 6 months prior to study, or hormonal contraceptives within 14 days before dosing

Conditions

Healthy Volunteers

Locations

  • ClinSync Clinical Research Pvt. Ltd. — Hyderabad, India
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record