Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

NCT07674446 | Recruiting Phase 1 DMC

• 1 other identifier: BE-024-2025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide

  AUC0-t calculated using the linear trapezoidal method. The 90% confidence interval of the geometric least square mean ratio (Test/Reference) must fall within 80.00-125.00% to establish bioequivalence.

  Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose

Secondary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide

  Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose

• Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Diosmetin-3-O-Glucuronide

  Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of Diosmetin-3-O-Glucuronide

  Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose

• Apparent First-Order Terminal Elimination Half-Life (t1/2) of Diosmetin-3-O-Glucuronide

  Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose

• Incidence of Adverse Events

  Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)

Study Arms (2)

Dimotec 1000 mg (Test)

EXPERIMENTAL

Single oral dose of Dimotec 1000 mg film-coated tablet (Test product; Keri Pharma Hungary Kft., manufactured by MEDITOP Gyogyszeripari Kft.) administered under fed conditions (30 minutes after a high-fat, high-calorie breakfast) with approximately 240 mL of water, in sitting upright posture.

Drug: Dimotec 1000 mg film-coated tablet

Detralex 1000 mg (Reference)

ACTIVE COMPARATOR

Single oral dose of Detralex 1000 mg film-coated tablets (Reference product; Les Laboratoires Servier Industrie, France, manufactured by Servier (Ireland) Industries Ltd.) administered under fed conditions (30 minutes after a high-fat, high-calorie breakfast) with approximately 240 mL of water, in sitting upright posture.

Drug: Detralex 1000 mg film-coated tablets

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.

Also known as: Diosmin 1000 mg

Dimotec 1000 mg (Test)

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.

Also known as: Daflon 1000 mg

Detralex 1000 mg (Reference)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keri Pharma Hungary Kft: lead

Study Sites (1)

ClinSync Clinical Research Pvt. Ltd.

Hyderabad, India

RECRUITING

MeSH Terms

Interventions

Diosmin; S 5682

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sharath Reddy A, MBBS

  ClinSync Clinical Research Pvt. Ltd., Hyderabad, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orsolya Gyurjan, PharmD

CONTACT

+36 52 502 610; info@keri.hu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study. The investigator, clinical team, and study participants are aware of the treatment assignments. Bioanalytical personnel are blinded to the randomization scheme.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Four-period, two-sequence, full-replicate crossover design. Sequence 1: T-R-T-R; Sequence 2: R-T-R-T. Washout period of at least 14 days between successive treatments. Total study duration approximately 60 days.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)