A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions

NCT07091669 | Active Not Recruiting Phase 1

• 1 other identifier: BCAM/23/Tam-BE/002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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), after single dose administration in healthy adult male subjects under fed conditions.

Conditions

Healthy Volunteers; Male

Keywords

Bioequivalence; Tamsulosin

Outcome Measures

Primary Outcomes (3)

• • Cmax (maximum plasma concentration),

  Maximum Plasma Concentration

  72 hours post dose

• • AUC0-t

  Area under the plasma concentration curve from administration to last observed concentration at time t

  72 hours post dose

• AUC0-inf

  Area under the plasma concentration curve extrapolated to infinite time

  72 hours post dose

Secondary Outcomes (7)

• tmax

  72 hours post dose

• λz

  72 hours post dose

• AUCResid

  72 hours post dose

• t1/2

  72 hours post dose

• AUC0-24

  24 hours post dose

Other Outcomes (5)

• Incidence of Adverse Events (AEs)

  21 days

• Proportion with treatment-related adverse events

  21 days

• Proportion of subjects with Serious Adverse Events (SAEs)

  21 days

Study Arms (2)

Tamsulosin 0.4 mg prolonged-release tablets (Synthon Hispania SL, Spain)

EXPERIMENTAL

Single dose administration (0.4 mg) with with 240 ml of water after a high-calorie, high fat breakfast

Drug: Tamsulosin (0.4 mg/j)

Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma

ACTIVE COMPARATOR

Single dose administration (0.4 mg) with with 240 ml of water after a high-calorie, high fat breakfast

Drug: Tamsulosin (0.4 mg/j)

Interventions

Tamsulosin (0.4 mg/j) DRUG

Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain)

Tamsulosin 0.4 mg prolonged-release tablets (Synthon Hispania SL, Spain)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Tamsulosin is indicated for the treatment of benign prostatic hyperplasia (BPH). Therefore, only male subjects are included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify 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, 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.
• 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.

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (1)

"Tonus-Les" LLC

Yerevan, Akunk, 0037, Armenia

Location

Related Links

• Related Info

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Shougher Heboyan, MD

  "Tonus-Les" LLC, 2/1 Varshavyan street. 0037 Yerewan, Armenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, single-dose, two-period, two-treatment, two-sequence crossover bioequivalence study

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: June 16, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 22, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)