Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT07091669
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:
NCT07091669
Study Brief:
Protocol Section:
NCT07091669