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Compares treatment options for Healthy Volunteer Male Subjects
Official title A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
ClinicalTrials.gov ID: NCT07156916
What this study is testing
What is Tamsulosin (0.4 mg/j)?
Tamsulosin (0.4 mg/j) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteer male subjects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), after single dose administration in healthy adult male subjects under fasting conditions.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and...
- Healthy male people aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.
- Verified diagnosis of being "healthy" according to results of standard clinical, laboratory and instrumental methods of examination.
- Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg/m2.
- Non-smokers (for at least 3 months).
You likely can't join if
- History or presence of allergies.
- Known hypersensitivity or intolerance to tamsulosin and/or other alpha 1 adreno-receptor antagonists and/or any other excipient of the study drugs.
- History of drug-induced angioedema.
- History, presence or necessity of glaucoma or cataract surgery.
- History or presence of acute or chronic diseases of cardiovascular (including arterial hypotension), bronchopulmonary, nervous, endocrine...
- Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.
See the full eligibility criteria
- Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Healthy male people aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.
- Verified diagnosis of being "healthy" according to results of standard clinical, laboratory and instrumental methods of examination.
- Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg/m2.
- Non-smokers (for at least 3 months).
- people should be willing to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraception during participation in the study and for 30 days thereafter. Double-barrier contraceptive method...
- History or presence of allergies.
- Known hypersensitivity or intolerance to tamsulosin and/or other alpha 1 adreno-receptor antagonists and/or any other excipient of the study drugs.
- History of drug-induced angioedema.
- History, presence or necessity of glaucoma or cataract surgery.
- History or presence of acute or chronic diseases of cardiovascular (including arterial hypotension), bronchopulmonary, nervous, endocrine, reproductive systems (including ejaculation disorders), and also diseases of the...
- Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.
- The presence of any other condition which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate...
- Surgery on the gastrointestinal tract (except appendectomy).
- Deviations from the normal parameters in clinical blood count analysis, biochemical blood analysis, urinalysis.
- History or presence of orthostatic hypotension or syncope.
- Systolic blood pressure measured in a sitting position, less than 100 mmHg or above 130 mmHg and/or diastolic blood pressure below 60 mmHg or above 89 mmHg.
- Heart rate less than 60 or more than 80 beats per minute.
- Deviation on the ECG intervals and heart rate or ECG morphology.
- Positive test results for HIV or hepatitis B or C or syphilis at screening.
- Positive test result for cotinine in the urine at screening or before randomisation.
- Positive screen for drugs or alcohol at screening or before randomisation.
- Known or suspected drug or alcohol abuse as judged by the Investigator.
- Alcohol consumption more than 10 units of alcohol a week (1 unit equivalent to 200 ml of dry wine or 50 ml of strong alcoholic drinks or 500 ml of beer) during the six months prior to the first administration of the IMP.
- Intake of xanthine containing substances (e.g., coffee, tea, chocolate, energy drinks, cola) as well as citrus fruits (grapefruit, grapefruit juice etc.) and cranberry (including juices, fruit drinks, etc.) within the...
- Administration of medicines that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazol, cimetidin, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics, etc.)...
- The use of depot-forms of any drugs for 3 months or 5 half-lives (whatever is longer) before screening.
- Use of any prescribed or non-prescribed medication, herbal remedies, vitamins and minerals during the two weeks prior to the first administration of the IMP or longer (at least 5 elimination half-lives) if the...
- Mental, physical and other reasons that do not allow the people according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess...
- Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 hours before the IMP administration.
- people who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet [less than 1000 cal/day]) during the 28 days prior to the first IMP administration and intention to maintain the diet...
- Intention to perform excessive physical activities during the trial.
- Plasma donation within one month from screening or blood donation/blood loss \>500 ml within 3 months before screening.
- Unwillingness or inability to follow the procedures and restrictions outlined in the protocol and the ICF.
- Participation in another clinical study within 3 months before the first IMP administration.
- Difficulty swallowing tablets or fasting or consuming standard meals.
- Any reason in the opinion of the Investigator, would prevent the subject from participating in the study.
- Scheduled to have vaccination during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Ankuk Region, Armenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Ankuk Region, Armenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.