Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Finasteride · 2 trials · 1 indication
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, ...
Finasteride is a small molecule drug being developed by Teva Pharmaceutical Industries Limited. In the clinical trials listed, it is being studied in healthy male volunteers to assess the pharmacokinetics of 5 mg tablets under fasting and non-fasting conditions. The drug is currently in Phase 1 clinical development.
Finasteride is being developed by Teva Pharmaceutical Industries Limited, which is publicly traded under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.
Finasteride is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy male volunteers. The drug is investigational and has not been approved for any indication based on the data provided.
Finasteride has two completed Phase 1 trials: NCT00835666, a fasting study with 32 participants, and NCT00835796, a non-fasting study with 20 participants. Both trials enrolled healthy males aged 18 years and older in the United States.
The data provided does not list alternative names for Finasteride. The drug is being studied as 5 mg tablets in clinical trials. No other names are mentioned in the available information.