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 being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for healthy volunteers. The drug is being studied in two completed trials with a total enrollment of 72 participants.
Famciclovir is being studied for use in healthy volunteers. The clinical trials are designed to evaluate the drug under fasting and non-fasting conditions. It is not yet approved for any specific disease or condition, as it is still in early-stage clinical development.
Famciclovir is being developed by Teva Pharmaceutical Industries Limited, which is publicly traded under the ticker symbol TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's effects in healthy volunteers.
Famciclovir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The two Phase 1 trials have been completed, and the drug is not yet in later-stage clinical trials.
Famciclovir has two completed Phase 1 clinical trials: NCT00834431, which studies the drug under fasting conditions, and NCT00834444, which studies it under non-fasting conditions. Both trials enrolled 36 healthy volunteers each and were conducted in the United States and Canada.
Famciclovir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have evaluated the drug in healthy volunteers, but it has not yet received regulatory approval for any medical use.