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 an investigational small molecule being studied in healthy volunteers. It is being developed by Teva Pharmaceutical Industries Limited (TEVA) and is currently in Phase 1 clinical development. The drug has been evaluated in two completed trials with a total enrollment of 90 participants.
Trandolapril is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials for this small molecule drug in healthy volunteers.
Trandolapril is in Phase 1 clinical development. It has completed two Phase 1 trials, both of which are finished, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
Trandolapril has been studied in two completed Phase 1 trials: NCT00840073, a non-fasting study with 50 participants, and NCT00840632, a fasting study with 40 participants. Both trials enrolled healthy volunteers aged 18 years and older in Canada.
Trandolapril is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have been conducted in healthy volunteers to evaluate the drug under fasting and non-fasting conditions.