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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835666 | Finasteride 5 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Jun 1, 2002 | Jun 1, 2002 | Aug 19, 2024 | 1 | United States |
| NCT00835796 | Finasteride 5 mg Tablets, Non-fasting | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2002 | Jul 1, 2002 | Aug 19, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUCinf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Finasteride | EXPERIMENTAL | Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period |
| Proscar® | ACTIVE_COMPARATOR | Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Finasteride 5 mg tablets | DRUG | 1 x 5 mg, single dose fasting |
| PROSCAR® | DRUG | 1 x 5 mg, single dose fasting |
| PROSCAR® 5mg tablets | DRUG | 1 x 5 mg, single dose fasting |
Inclusion Criteria: * All subjects selected for this study will be male non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, ...