Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Terbinafine Hydrochloride Tablets 250 mg |
| 2 | ACTIVE_COMPARATOR | Lamisil® Tablets 250 mg |
| Name | Type | Description |
|---|---|---|
| Terbinafine Hydrochloride Tablets 250 mg | DRUG | 250mg, single dose fasting |
| Lamisil® Tablets 250 mg | DRUG | 250mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...
Terbinafine is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials for use in healthy individuals, with no specific disease condition targeted in the studies. The drug is being developed by Viatris Inc.
Terbinafine 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 in healthy volunteers.
Terbinafine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing studies are designed to assess the drug's behavior in healthy subjects.
Terbinafine has two completed Phase 1 clinical trials: NCT00647647, a fasting study of Terbinafine Hydrochloride Tablets 250 mg versus Lamisil Tablets 250 mg, and NCT00648713, a fed study of the same formulations. Both trials enrolled 36 healthy volunteers each in the United States.
Terbinafine is being studied in comparison to Lamisil, which is a brand name for terbinafine hydrochloride. The clinical trials are designed to compare the pharmacokinetics of Terbinafine Hydrochloride Tablets 250 mg with Lamisil Tablets 250 mg under fasting and fed conditions.