Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trandolapril · 2 trials · 1 indication
| 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...
Trandolapril is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is an ACE inhibitor that has been studied in Phase 1 clinical trials. The trials listed for Trandolapril were bioequivalence studies conducted in healthy adult volunteers in India, and both have been completed.
Trandolapril targets ACE, or angiotensin-converting enzyme. It belongs to the ACE inhibitor class, meaning it acts by inhibiting this enzyme. This mechanism is the basis for its study as a small molecule therapeutic developed by Dr. Reddy's Laboratories Ltd under the ticker RDY.
Trandolapril is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the clinical trials of Trandolapril listed in the registry, including two Phase 1 bioequivalence studies conducted in India.
Trandolapril is in Phase 1 clinical development. Both registered trials of Trandolapril are Phase 1 bioequivalence studies, and both have been completed. There are no active trials of Trandolapril currently listed, and the drug is investigational rather than approved.
Trandolapril has been studied in two completed Phase 1 trials: NCT01164800, a bioequivalence study of Trandolapril 4 mg tablets under fed conditions, and NCT01164787, the same bioequivalence study under fasting conditions. Each trial enrolled 52 healthy adult volunteers in India, for a total enrollment of 104.
Yes. Both Trandolapril trials, NCT01164800 and NCT01164787, were randomized and used an active control design. Neither trial was double blind. Both were Phase 1 bioequivalence studies of Trandolapril 4 mg tablets in healthy volunteers and have been completed.