Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study

ConditionHealthy Volunteers

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorKeri Pharma Hungary Kft

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: Dimotec 1000 mg (Test)Experimental treatment 1 intervention

Group B: Detralex 1000 mg (Reference)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame