NDAORALCAPSULE
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Mechanism of Action
5-alpha Reductase Inhibitors
Pharmacologic Class:
5-alpha Reductase Inhibitor
Clinical Trials (3)
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
Started Jul 2015
56 enrolled
Prostatic Hyperplasia
Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States
Started Jul 2014
84 enrolled
Prostatic Hyperplasia
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Started Feb 2014
78 enrolled
Urologic Diseases