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Dutabit Plus (Dutasteride and tamsulosin hydrochloride 0.5/0.4 mg),Duodart (Dutasteride and tamsulosin hydrochloride 0.5/0.4 mg)

3 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 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
A Single Dose, Randomized, Open-label,Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Dutasteride & Tamsulosin Hydrochloride 0.5/0.4 mg Capsules (Dutabit Plus) & Duodart (Dutasteride & Tamsulosin Hydrochloride) 0.5/0.4 mg Hard Capsules (Reference) in Healthy Thai Male Volunteers
Active, not recruitingTCTR20241002003
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: 2025-06-16Target: 40Updated: 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