Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Famciclovir · 2 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Famciclovir 500 mg Tablets | DRUG | 1 x 500 mg, single-dose fasting |
| Famvir® 500 mg Tablets | DRUG | 1 x 500 mg, single-dose fasting |
Inclusion Criteria: * All subjects selected for this study will be at least 18 years of age. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history. *...
Famciclovir is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been publicly disclosed.
Famciclovir is developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company listed under the ticker symbol TEVA. Teva is the sponsor behind the clinical studies of this small molecule asset.
Famciclovir is in Phase 1 clinical development. It is an investigational drug and is not described as approved. Two Phase 1 trials have been completed, and no trials are currently active.
Famciclovir has been evaluated in two completed Phase 1 trials: NCT00834444, which studied Famciclovir 500 mg tablets under non-fasting conditions, and NCT00834431, which studied the same tablets under fasting conditions. Both enrolled 36 healthy volunteers in the United States and Canada.