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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01132040 | Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Aug 1, 2006 | Sep 1, 2006 | May 27, 2010 | 1 | India |
| 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...