Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Terbinafine Hydrochloride | EXPERIMENTAL | Terbinafine Hydrochloride Tablets, 250 mg of Dr.Reddy's Laboratories Limited |
| Lamisil® 250 mg Tablets | ACTIVE_COMPARATOR | Lamisil® 250 mg Tablets of Novartis |
| Name | Type | Description |
|---|---|---|
| Terbinafine Hydrochloride Tablets, 250 mg | DRUG | Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited. |
Inclusion Criteria: * Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' data base). ---Subjects must meet all of the following criteria in order ...
Terbinafine is a small molecule drug being studied for use in healthy, fasting individuals. It is currently in Phase 1 clinical development by Dr. Reddy's Laboratories Ltd. The drug is being evaluated in bioequivalence studies to compare the pharmacokinetics of Terbinafine Hydrochloride Tablets, 250 mg.
Terbinafine is an antifungal agent that works by inhibiting the enzyme squalene epoxidase, which is essential for the synthesis of ergosterol, a key component of fungal cell membranes. This inhibition leads to the accumulation of squalene and disruption of the fungal cell membrane, resulting in the death of the fungus.
Terbinafine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of its Terbinafine Hydrochloride Tablets, 250 mg formulation.
Terbinafine is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trials are focused on assessing the bioequivalence of the drug formulation in healthy volunteers under fasting and fed conditions.
Terbinafine has been studied in two completed Phase 1 clinical trials. The first trial, NCT01286688, is a bioequivalence study of Terbinafine Hydrochloride Tablets, 250 mg under fasting conditions with 36 participants. The second trial, NCT01286701, is a similar study under fed conditions with 18 participants. Both trials were conducted in Canada.
Terbinafine is the active ingredient in the brand-name product Lamisil. However, the drug being developed by Dr. Reddy's Laboratories Ltd is a generic version of Terbinafine Hydrochloride Tablets, 250 mg. The clinical trials are designed to demonstrate bioequivalence to the reference product.