Actively Recruiting
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
Led by Berlin-Chemie AG Menarini Group · Updated on 2025-10-03
46
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent and comply with study requirements
- Healthy males aged 18 to 45 years at consent
- Confirmed healthy status by clinical, laboratory, and instrumental exams
- Body weight between 50 and 120 kg and BMI between 18.5 and 30.0 kg/m2
- Non-smokers for at least 3 months
- Willing to remain abstinent or use double-barrier contraception during the study and for 30 days after
You will not qualify if you...
- History or presence of allergies
- Known hypersensitivity or intolerance to tamsulosin, alpha 1 blockers, or study drug excipients
- History of drug-induced angioedema
- History or need for glaucoma or cataract surgery
- History or presence of acute or chronic diseases affecting cardiovascular, bronchopulmonary, nervous, endocrine, reproductive, gastrointestinal, liver, urinary, kidney, blood, or mental health
- Recent acute infections within 4 weeks before dosing
- Conditions posing risk or affecting participation as judged by investigator
- Gastrointestinal surgery except appendectomy
- Abnormal blood count, biochemical, or urine tests
- History or presence of orthostatic hypotension or syncope
- Blood pressure outside 100-130 mmHg systolic or 60-89 mmHg diastolic
- Heart rate outside 60-80 beats per minute
- ECG abnormalities
- Positive tests for HIV, hepatitis B or C, syphilis, cotinine, drugs, or alcohol
- Known or suspected drug or alcohol abuse
- Alcohol intake exceeding 10 units per week in past 6 months
- Recent intake of xanthine-containing substances, citrus fruits, or cranberry within 72 hours before dosing
- Recent use of medicines affecting circulation or liver function within 2 months or 5 half-lives
- Use of depot drug forms within 3 months or 5 half-lives
- Use of medications with long half-life within 2 weeks before dosing
- Mental, physical, or other reasons impairing study compliance
- Recent dehydration within 48 hours before dosing
- Special diets within 28 days before dosing
- Intent to perform excessive physical activity during the study
- Recent plasma or blood donation
- Unwillingness or inability to follow study procedures
- Participation in another clinical trial within 3 months
- Difficulty swallowing tablets or following fasting or meal requirements
- Any investigator-determined reason preventing participation
- Scheduled vaccination during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Tonus-Les" LLC
Yerevan, Ankuk Region, Armenia, 0037
Actively Recruiting
Research Team
K
Kai Schumacher, MD
CONTACT
A
Anja Pagenkopf
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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