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Also known as Proscar, Propecia
Finasteride · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Finasteride tablets 5 mg | EXPERIMENTAL | Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited |
| Proscar 5 mg Tablets | ACTIVE_COMPARATOR | Proscar 5 mg Tablets of Merck \& Co. Inc |
| Finasteride | EXPERIMENTAL | Finasteride tablets 1 mg of Dr. Reddy's |
| Propecia | ACTIVE_COMPARATOR | Propecia 1 mgTablets of Merck \& Co., |
| Name | Type | Description |
|---|---|---|
| Finasteride | DRUG | Finasteride Tablets 5 mg |
Inclusion Criteria: 1. Males, 18-65 years of age (inclusive). 2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures. 3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening...
Finasteride is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is a 5-alpha reductase inhibitor that targets the SRD5A2 enzyme. The clinical program described here consists of Phase 1 bioequivalence studies conducted in healthy male volunteers.
Finasteride targets SRD5A2, also known as 5-alpha reductase type 2. It acts as an inhibitor of this enzyme. By inhibiting SRD5A2, finasteride interferes with the enzymatic conversion pathway associated with this target. This mechanism underlies the drug's activity as a small molecule 5-alpha reductase inhibitor.
Finasteride in this program is developed by Dr. Reddy's Laboratories Ltd, an Indian pharmaceutical company whose shares trade under the ticker RDY. The company sponsored the Phase 1 bioequivalence studies of finasteride tablets at both the 1 mg and 5 mg strengths.
Finasteride is in Phase 1 development under Dr. Reddy's Laboratories Ltd. All four listed trials are Phase 1 bioequivalence studies, and all four are completed, with no active trials remaining. These studies evaluated finasteride tablets in healthy male volunteers rather than in patients with a disease indication.
Four completed Phase 1 bioequivalence trials are registered: NCT01264302 and NCT01264289 tested finasteride 5 mg tablets under non-fasting and fasting conditions in the United States, while NCT01133457 and NCT01133444 tested finasteride 1 mg tablets under fed and fasting conditions in Canada. Total enrollment across these studies was 100 participants.
The finasteride trials were randomized, active-controlled Phase 1 bioequivalence studies. They were not double-blind and did not use biomarker selection. Each study enrolled healthy male volunteers aged 18 years and older, with 24 to 26 participants per trial, conducted in the United States and Canada.