Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study
Recruiting
Phase 1Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Keri Pharma Hungary Kft · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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Eligibility Criteria
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 serologic…
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
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