Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT07091669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Berlin-Chemie AG Menarini Group
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Open Label, Single-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, Under Fed Conditions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
In this Phase I study, the test medication (Tamsulosin hydrochloride 0.4 mg prolonged-release tablets by Snthon, Hispania SL, Spain) is compared to the reference medication ( Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg, prolonged-release film-coated tablets by Astellas Pharma Europe B.V., the Netherlands) in terms of bioequivalence of the tested formulation under fed conditions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: