Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01264289 | Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Nov 1, 2006 | Nov 1, 2006 | Dec 21, 2010 | 1 | United States |
| NCT01264302 | Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Nov 1, 2006 | Nov 1, 2006 | Dec 21, 2010 | 1 | United States |
| NCT01133444 | Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2002 | May 1, 2002 | Jul 12, 2010 | 1 | Canada |
| NCT01133457 | Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2002 | May 1, 2002 | May 28, 2010 | 1 | Canada |
| 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...