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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00840073 | Trandolapril 4 mg Tablet Under Non-Fasting Conditions | PHASE1 | COMPLETED | 50 | — | — | Oct 1, 2004 | Nov 1, 2004 | Aug 20, 2024 | 1 | Canada |
| NCT00840632 | Trandolapril 4 mg Tablet Under Fasting Conditions | PHASE1 | COMPLETED | 40 | — | — | Oct 1, 2004 | Nov 1, 2004 | Aug 20, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Trandolapril | EXPERIMENTAL | Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period |
| Mavik® | ACTIVE_COMPARATOR | Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Trandolapril 4 mg Tablets | DRUG | 1 x 4 mg, single-dose fed |
| Mavik® 4 mg Tablets | DRUG | 1 x 4 mg, single-dose fed |
Inclusion Criteria: * Healthy, non-smoking, male and female subjects, 18 years of age or older. * BMI greater than or equal to 19 and less than or equal to 30. * Negative for HIV, Hepatitis B surface antigen and Hepatitis C antibody, urine drugs of abuse test (marijuana, amphetamines, barbiturates,...