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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01164787 | Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions | PHASE1 | COMPLETED | 52 | — | — | Mar 1, 2006 | May 1, 2006 | Jul 19, 2010 | 1 | India |
| NCT01164800 | Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions | PHASE1 | COMPLETED | 52 | — | — | Mar 1, 2006 | May 1, 2006 | Jul 19, 2010 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Trandolapril | EXPERIMENTAL | Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited |
| Mavik® | ACTIVE_COMPARATOR | Mavik® 4 mg Tablets of Abbott Laboratories, USA. |
| Name | Type | Description |
|---|---|---|
| Trandolapril | DRUG | Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited |
| Mavik | DRUG | Mavik® 4 mg Tablets of Abbott Laboratories, USA. |
Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index of ≥ 18.5 kg/m2 and ≤24.9 kg/m2, with body weight not less than 50 kg * Absence...