Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. FDA label
Also known as Plavix
Clopidogrel · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Clopidogrel | EXPERIMENTAL | Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited |
| Plavix | ACTIVE_COMPARATOR | Clopidogrel Tablet 300 mg |
| Name | Type | Description |
|---|---|---|
| Clopidogrel | DRUG | Clopidogrel Tablets 300 mg |
Inclusion Criteria: * Healthy adult human male volunteers between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India. * Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2. * Not having any ...
Clopidogrel is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is in Phase 1 clinical development, with two completed bioequivalence trials conducted under fasting conditions. The trials enrolled a total of 121 healthy volunteers in India and Canada.
Clopidogrel targets P2RY12, a receptor that is antagonized by the drug. This target class is an antagonist. The molecular target is P2RY12, and the drug is a small molecule.
Clopidogrel is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY.
Clopidogrel is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are ongoing.
Clopidogrel has been studied in two completed Phase 1 trials: NCT01621750, a bioequivalence study of 300 mg tablets under fasting conditions in India, and NCT01506713, a bioequivalence study of 75 mg tablets under fasting conditions in Canada.