Healthy Adult Males VolunteersPhase 1NCT07146711
A Comparative Bioavalability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tabsulosine 0.4 mg Tablets in Healthy Adult Male Subjects, at Steady State
A Phase 1 study testing Tamsulosin (0.4 mg/j) and Omnic Ocas®, in people with Healthy Adult Males Volunteers, run by Berlin-Chemie AG Menarini Group at 1 site in Armenia.
Trial summary
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), in healthy adult… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males Volunteers
- What is being tested?
- Tamsulosin (0.4 mg/j) and Omnic Ocas®,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteArmenia
- Study dates
- 3 Mar 2025to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 subjects 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).
- Subjects 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: condom used together with spermicidal foam/gel/film/cream/suppository.
Who cannot join
- History or presence of allergies.
- Known hypersensitivity or intolerance to tamsulosin and/or other alpha1 adreno-receptor antagonists and/or any 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 gastrointestinal tract, liver (including hepatic insufficiency), urinary tract and kidneys (including renal insufficiency), blood, mental diseases; history of convulsive attacks.
- Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.
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- 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 in the study.
- 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 last 72 hours before the IMP administration.
- 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.) less than 2 months or 5 half-lives (whatever is longer) before screening.
- 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 medication has a long half-life.
- Mental, physical and other reasons that do not allow the subjects according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.
- Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 hours before the IMP administration.
- Subjects 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 during the study.
- Intention to perform excessive physical activities during the trial.
- Plasma donation within one month of 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised, Open Label, Multiple Dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V., the Netherlands), in Healthy Adult Male Subjects, at Steady State
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), in healthy adult male subjects, at steady state.
Read the detailed description
The assessment of the bioequivalence of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), and Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands) after multiple dose administration in healthy male subjects at steady state.
- Conditions
- Healthy Adult Males Volunteers
- Being tested
- Tamsulosin (0.4 mg/j), Omnic Ocas®,
- Keywords
- Bioequivalence, Tamsulosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin (0.4 mg/j)Drug
Multiple dose administration (7 days)
Omnic Ocas®,Drug
Multiple dose administration (7 days)
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets of Synthon Hispania SL, Spain | Experimental | Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Pharma Europe B.V., the Netherlands Receives: Drug: Tamsulosin (0.4 mg/j) |
| Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Phar | Active comparator | Multiple dose administration (7 days) Receives: Drug: Omnic Ocas®, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
Maximum plasma concentration at steady state
Measured: 7 days
AUC(0-tau),ss
Area under the curve at steady state
Measured: 7 days
Ctau,ss
Plasma concentration at the end of the dosing interval at steady state
Measured: 7 days
Secondary outcomes (7)
Cavg,ss
Average concentration at steady state
Measured: 7 days
Tmax,ss
Time to maximum plasma concentration at steady state
Measured: 7 days
Cmin,ss
Minimum plasma concentration at steady state
Measured: 7 days
Kel
Terminal rate constant
Measured: 7 days
PTF
Peak-trough fluctuation over one dosing interval at steady state
Measured: 7 Days
T 1/2
Plasma half life
Measured: 7 days
Swing
(Cmax,ss-Cmin,ss)/ Cmin,ss
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Mar 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Males VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, multiple-dose, two-period, two-treatment, two-sequence crossover bioequivalence study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin-Chemie AG Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146711
- Sponsor's protocol ID
- BCAM/23/Tam-BE/001
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No publication in an ICMJE journal is planned
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open Label, Multiple Dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V., the Netherlands), in Healthy Adult Male Subjects, at Steady State
- ClinicalTrials.gov ID
- NCT07146711
- Acronym / sponsor ID
- BCAM/23/Tam-BE/001
- Conditions
- Healthy Adult Males Volunteers
- Keywords
- Bioequivalence, Tamsulosin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Berlin-Chemie AG Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), in healthy adult male subjects, at steady state.
Detailed description
The assessment of the bioequivalence of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), and Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands) after multiple dose administration in healthy male subjects at steady state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized, multiple-dose, two-period, two-treatment, two-sequence crossover bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets of Synthon Hispania SL, Spain | Experimental | Drug: Tamsulosin (0.4 mg/j)Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Pharma Europe B.V., the Netherlands |
| Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Phar | Active comparator | Drug: Omnic Ocas®,Multiple dose administration (7 days) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 subjects 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).
Key exclusion criteria (32 listed)
- History or presence of allergies.
- Known hypersensitivity or intolerance to tamsulosin and/or other alpha1 adreno-receptor antagonists and/or any 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 gastrointestinal tract, liver (including hepatic insufficiency), urinary tract and kidneys (including renal insufficiency), blood, mental diseases; history of convulsive attacks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin (0.4 mg/j)Multiple dose administration (7 days) | Drug | Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets of Synthon Hispania SL, Spain |
| Omnic Ocas®,Multiple dose administration (7 days) | Drug | Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets of Astellas Phar |
Primary outcome
Cmax,ss
Time frame: 7 days
Maximum plasma concentration at steady state
AUC(0-tau),ss
Time frame: 7 days
Area under the curve at steady state
Ctau,ss
Time frame: 7 days
Plasma concentration at the end of the dosing interval at steady state
7 secondary outcomes
Cavg,ss
Time frame: 7 days
Tmax,ss
Time frame: 7 days
Cmin,ss
Time frame: 7 days
Kel
Time frame: 7 days
PTF
Time frame: 7 Days
T 1/2
Time frame: 7 days
Swing
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No publication in an ICMJE journal is planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tamsulosin (0.4 mg/j) and Omnic Ocas®, in people with Healthy Adult Males Volunteers, run by Berlin-Chemie AG Menarini Group at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.