Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Terbinafine | EXPERIMENTAL | Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period |
| Lamisil® | ACTIVE_COMPARATOR | Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Terbinafine HCl 250mg tablets | DRUG | 1 x 250 mg |
| Lamisil® 250 mg Tablets | DRUG | 1 x 250 mg |
Inclusion Criteria: * Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less. * Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. * Signed and dated informed consent form, which meets all criter...
Terbinafine is an investigational small molecule being studied in healthy volunteers. It is a 250 mg tablet formulation developed by Teva Pharmaceutical Industries Limited. The drug is currently in Phase 1 clinical development, with studies evaluating its pharmacokinetics under fasting and non-fasting conditions.
Terbinafine is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers.
Terbinafine is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. Two Phase 1 trials have been completed, both evaluating the 250 mg tablet formulation.
Terbinafine has two completed Phase 1 clinical trials: NCT00833586, a study of Terbinafine HCl 250 mg tablets under fasting conditions with 28 participants, and NCT00833664, a study of the same tablet under non-fasting conditions with 22 participants. Both trials were conducted in the United States.
Terbinafine and Terbinafine HCl refer to the same drug substance. The clinical trials NCT00833586 and NCT00833664 both evaluate Terbinafine HCl 250 mg tablets, with the HCl indicating the hydrochloride salt form of the drug.