Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Primidone · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Primidone | EXPERIMENTAL | Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories |
| Mysoline | ACTIVE_COMPARATOR | Mysoline Tablets of Yamanouchi Pharma Technologies Inc, |
| Name | Type | Description |
|---|---|---|
| Primidone | DRUG | Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: 1. Subjects who will provide written informed consent. 2. Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg. 3. Havi...
Primidone is an investigational small molecule being studied in healthy volunteers. The drug is currently in Phase 1 clinical development. It is being evaluated in a bioequivalence study of Primidone tablets 50 mg under fasting conditions.
Primidone is being developed by Dr. Reddy's Laboratories Ltd (ticker: RDY). The company is conducting clinical trials for this drug, which is currently in Phase 1 development.
Primidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers as part of a bioequivalence trial.
Primidone is associated with one completed clinical trial, NCT01132040. This was a Phase 1 bioequivalence study of Primidone tablets 50 mg under fasting conditions, conducted in India with 24 healthy male participants.
Primidone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy volunteers for bioequivalence purposes, and its safety and efficacy have not been established.