Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 1 trial · 1 indication
| 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 developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied as Terbinafine Hydrochloride Tablets, 250 mg. The program is in Phase 1 clinical development, and the single registered trial was conducted in healthy adult volunteers under fasting conditions.
The registered clinical study of Terbinafine Hydrochloride Tablets, 250 mg was conducted in healthy volunteers under fasting conditions, not in a patient disease population. The trial listing describes the condition as fasting, which reflects the bioequivalence testing design rather than a therapeutic indication. No approved indication is stated for this development program.
Terbinafine Hydrochloride Tablets, 250 mg is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker RDY. Dr. Reddy's is the sponsor associated with the registered clinical trial of this 250 mg tablet formulation.
Terbinafine Hydrochloride Tablets, 250 mg is in Phase 1 development. One Phase 1 trial has been registered, and it is listed as completed, with no active trials ongoing. The program has not been described as approved, so it remains an investigational asset in clinical development.
One clinical trial is registered for Terbinafine Hydrochloride Tablets, 250 mg: NCT01286688, titled Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions. It was a Phase 1, randomized, active-controlled study with 36 enrolled healthy volunteers, conducted in Canada, and it is now completed.