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Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study (Diosmin)

7 septembre 2026 mis à jour par: Keri Pharma Hungary Kft

Comparative Bioavailability Study of Dimotec 1000 mg Film-coated Tablet Versus Detralex 1000 mg Film Coated Tablets in Healthy Subjects Under Fed Conditions: Randomized, Four-period, Full-replicate Crossover

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is an open-label, balanced, randomized, single-dose, two-treatment, two-sequence, four-period, full-replicate, crossover, comparative bioavailability study conducted in healthy adult human participants under fed conditions.

A total of 72 participants will be enrolled (with up to 6 stand-by participants), targeting 64 completers. Participants will receive a single oral dose of either the Test product (Dimotec 1000 mg film-coated tablet) or Reference product (Detralex 1000 mg film-coated tablets) following an overnight fast of at least 10 hours and 30 minutes after consumption of a high-fat, high-calorie non-vegetarian breakfast (approximately 967 kcal; approximately 57.5% fat, 26.8% carbohydrate, 15.7% protein).

The study comprises four periods with a washout of at least 14 days between successive doses. Participants are housed for at least 60 hours pre-dose and up to 72 hours post-dose in each period.

Pharmacokinetic blood samples (4 mL each) are collected at 25 time points per period: pre-dose (-1.25, -1.00, -0.75 h) and post-dose 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. Plasma samples are assayed for diosmetin-3-O-glucuronide using a validated bioanalytical method.

Primary PK parameters: Cmax and AUC0-t. Secondary PK parameters: AUC0-inf, Tmax, t1/2, Kel, and Residual area.

Statistical analysis will be performed using SAS v9.4 or higher. ANOVA on ln-transformed Cmax and AUC0-t; 90% confidence intervals for the Test/Reference geometric least square mean ratio must fall within 80.00-125.00%. Reference-scaled average bioequivalence will be applied for Cmax if within-subject CV of the Reference exceeds 30%, with widened limits up to 69.84-143.19%.

The study is conducted at ClinSync Clinical Research Pvt. Ltd., Hyderabad, India.

Type d'étude

Interventionnel

Inscription (Estimé)

72

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Orsolya Gyurjan, PharmD
  • Numéro de téléphone: +36 52 502 610
  • E-mail: info@keri.hu

Lieux d'étude

  • Inde
      • Hyderabad, Inde
        • Recrutement
        • ClinSync Clinical Research Pvt. Ltd.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Dimotec 1000 mg (Test)
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.
Médicament: 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.
Autres noms:
  • Diosmin 1000 mg
Comparateur actif: Detralex 1000 mg (Reference)
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.
Médicament: 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.
Autres noms:
  • Daflon 1000 mg

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide
Délai: 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
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide
Délai: 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
The 90% CI of the geometric least square mean ratio (T/R) must be within 80.00-125.00%. Reference-scaled widening (up to 69.84-143.19%) applies if within-subject CV of the Reference is 30% or above.
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
Délai: 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 pharmacokinetic parameter calculated by non-compartmental analysis.
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
Délai: 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
Analysed using non-parametric Wilcoxon and median tests of treatment effect.
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
Délai: 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 pharmacokinetic parameter calculated by non-compartmental analysis.
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
Délai: Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
Safety assessments include vital signs (blood pressure, pulse rate, respiratory rate, body temperature), participant well-being monitoring, laboratory evaluations (haematology and biochemistry), and recording of adverse events graded by severity (Grades 1-5).
Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Keri Pharma Hungary Kft

Les enquêteurs

  • Chercheur principal: Sharath Reddy A, MBBS, ClinSync Clinical Research Pvt. Ltd., Hyderabad, India

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 juin 2026

Achèvement primaire (Réel)

16 août 2026

Achèvement de l'étude (Estimé)

29 décembre 2026

Dates d'inscription aux études

Première soumission

23 juin 2026

Première soumission répondant aux critères de contrôle qualité

23 juin 2026

Première publication (Réel)

29 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BE-024-2025

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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