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 an investigational small molecule being studied in healthy volunteers. It is being developed by Dr. Reddy's Laboratories Ltd. The drug is currently in Phase 1 clinical development, with two completed bioequivalence studies.
Trandolapril is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug in healthy volunteers.
Trandolapril is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 bioequivalence studies have been completed, with a total of 104 participants enrolled.
Trandolapril has two completed Phase 1 clinical trials: NCT01164787, a bioequivalence study of Trandolapril 4 mg tablets under fasting conditions, and NCT01164800, a bioequivalence study under fed conditions. Both trials enrolled 52 healthy volunteers each in India.
Trandolapril is being studied as a generic version of the reference drug. The clinical trials are designed to compare the bioequivalence of Dr. Reddy's Trandolapril 4 mg tablets against an active control, which is the standard approach for generic drug development.