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Finasteride · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Finasteride Tablets 5 mg |
| 2 | ACTIVE_COMPARATOR | Proscar® Tablets 5 mg |
| Name | Type | Description |
|---|---|---|
| Finasteride Tablets 5 mg | DRUG | 5mg, single dose fed |
| Proscar® Tablets 5 mg | DRUG | 5mg, single dose fed |
| Proscar Tablets 5 mg | DRUG | 5mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older 2. Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the ...
Finasteride is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the drug in healthy male participants. The drug is being studied for its effects in a controlled setting, though specific therapeutic indications have not been disclosed.
Finasteride is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and safety in healthy volunteers. Viatris is responsible for the ongoing development of this small molecule drug.
Finasteride is currently in Phase 1 clinical development. It has completed two Phase 1 trials, both of which have been completed. The drug is being studied in healthy volunteers, and it is still in the investigational stage, meaning it has not yet been approved for any medical use.
Finasteride has been studied in two completed Phase 1 clinical trials. The first trial, NCT00648791, was a fasting study comparing Finasteride tablets 5 mg to Proscar tablets 5 mg in 29 healthy male participants. The second trial, NCT00650377, was a fed study with 30 healthy male participants. Both trials were conducted in the United States.
Finasteride is being studied as a generic version of Proscar, a brand-name drug. The clinical trials compare Finasteride tablets 5 mg to Proscar tablets 5 mg to assess bioequivalence. While they contain the same active ingredient, Finasteride is the generic formulation being developed by Viatris Inc.
Finasteride is a small molecule drug that works by inhibiting the enzyme 5-alpha-reductase, which converts testosterone to dihydrotestosterone (DHT). By reducing DHT levels, it can affect androgen-dependent processes. However, the specific mechanism of action for the current Phase 1 studies in healthy volunteers has not been detailed.