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Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride.,Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride.

4 trials

Sponsors

International Bio Service Co., Ltd.

Conditions

Bioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fasting ConditionsBioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fed ConditionsBioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and Tamsulosin Hydrochloride) 0.5 mg/0.4 mg Hard Capsules (Reference) in Healthy Thai Male Volunteers under Fed ConditionsBioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fasting Conditions

Phase 1

A SingleDose,Randomized,Open-label,Two-wayCrossover BioequivalenceStudy of Fixed-doseCombination of Dutasteride-Tamsulosin Hydrochloride0.5/0.4mgCapsules(DutabitPlus)and Duodart(Dutasteride-tamsulosinhydrochloride)0.5/0.4mg hard capsules(Reference)in HealthyThaiMaleVolunteers underFasting Conditions
Active, not recruitingTCTR20240906001
International Bio Service Co., Ltd.Bioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fasting Conditions
Start: 2025-01-29Target: 48Updated: 2026-08-03
An Open-label, Randomized, Multiple Dose, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and Tamsulosin Hydrochloride) 0.5 mg/0.4 mg Hard Capsules (Reference)
Active, not recruitingTCTR20241115008
International Bio Service Co., Ltd.Bioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and Tamsulosin Hydrochloride) 0.5 mg/0.4 mg Hard Capsules (Reference) in Healthy Thai Male Volunteers under Fed Conditions
Start: 2025-07-23Target: 40Updated: 2026-08-03
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Fixed-dose Combination of Dutasteride and Tamsulosin Hydrochloride 0.5/0.4 mg Capsules and Reference Product (DUODART) in Healthy Thai Male Volunteers under Fasting Conditions
Active, not recruitingTCTR20260702001
International Bio Service Co., Ltd.Bioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fasting Conditions
Start: 2026-07-27Target: 48Updated: 2026-08-03
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Fixed-dose Combination of Dutasteride and Tamsulosin Hydrochloride 0.5/0.4 mg Capsules and Reference Product (DUODART) in Healthy Thai Male Volunteers under Fed Conditions
Active, not recruitingTCTR20260723005
International Bio Service Co., Ltd.Bioequivalence study in healthy Thai male volunteers Dutasteride and Tamsulosin Hydrochloride 0.5 mg/0.4 mg Capsules (Dutabit Plus) and Duodart (Dutasteride and tamsulosin hydrochloride) 0.5 mg/0.4 mg hard capsules (Reference) in Healthy Thai Male Volunteers under Fed Conditions
Start: 2026-12-15Target: 40Updated: 2026-08-03