Recruiting
Phase 1
Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study
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
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)
- Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) 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
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.
Trial sites (1)
| Facility | City | Region | Status |
| ClinSync Clinical Research Pvt. Ltd. |
Hyderabad |
India |
Recruiting |
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