Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00833586 | Terbinafine HCl 250 mg Tablet Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Jan 1, 2002 | Jan 1, 2002 | Aug 19, 2024 | 1 | United States |
| NCT00833664 | Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions | PHASE1 | COMPLETED | 22 | — | — | Jan 1, 2002 | Jan 1, 2002 | May 30, 2023 | 1 | United States |
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...