Generic vein health pill put to the test against Brand-Name version
NCT ID NCT07674446
First seen Jun 29, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This study checks whether a generic diosmin tablet (Dimotec) releases the same amount of active ingredient into the blood as the brand-name Detralex after a meal. Healthy adults aged 18 to 55 take a single dose of each tablet in random order, and blood samples are compared. The goal is to see if the two versions are bioequivalent, meaning they work the same in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Diosmin (a flavonoid used for vein health)
- What this could lead to
- If the two tablets are shown to be equivalent, it could offer a more affordable option for people needing diosmin therapy.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. Results may not predict real-world effectiveness or safety in people with vein disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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ClinSync Clinical Research Pvt. Ltd.
RECRUITINGHyderabad, India
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