Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trandolapril · 2 trials · 1 indication
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,...
Trandolapril is a small molecule drug developed by Teva Pharmaceutical Industries Limited under the ticker TEVA. It is being studied in Phase 1 clinical development. Its listed therapeutic area is categorized as Other, and the specific indications being pursued are undisclosed.
Trandolapril targets ACE, or angiotensin-converting enzyme, and is classified as an ACE inhibitor. This target class places it among small molecule agents that act on the renin-angiotensin system. The molecular target is recorded under ChEMBL identifier CHEMBL1519.
Trandolapril is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical development program for this small molecule ACE inhibitor.
Trandolapril is in Phase 1 clinical development. It is an investigational drug and is not described as approved. Two Phase 1 trials have been completed, and no trials are currently active.
Two completed Phase 1 trials have studied Trandolapril: NCT00840632, titled Trandolapril 4 mg Tablet Under Fasting Conditions, and NCT00840073, titled Trandolapril 4 mg Tablet Under Non-Fasting Conditions. Both enrolled healthy volunteers in Canada, with 40 and 50 participants respectively, for a total enrollment of 90.