🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT07674446
Recruiting Phase 1

Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

NCT07674446 · tracked via the Priya Life Science India tracker
Sponsor
Keri Pharma Hungary Kft
Phase
Phase 1
Started
2026-06-29
Last updated
2026-09-09

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

Dimotec 1000 mg film-coated tabletDetralex 1000 mg film-coated tablets

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ClinSync Clinical Research Pvt. Ltd. Hyderabad India Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07674446 on ClinicalTrials.gov ↗ ← All trials in India