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Atorvastatin Calcium · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Atorvastatin Calcium Tablets, 80 mg | EXPERIMENTAL | Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited |
| Lipitor 80 mg Tablets | ACTIVE_COMPARATOR | Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals |
| Atorvastatin Calcium Tablets, 40 mg | EXPERIMENTAL | Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited |
| Lipitor® 40 mg Tablets | ACTIVE_COMPARATOR | Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals |
| Name | Type | Description |
|---|---|---|
| Atorvastatin Calcium Tablets, 80 mg | DRUG | Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited |
| Atorvastatin Calcium Tablets, 40 mg | DRUG | Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: 1. Male and female subjects aged 18 - 55 (including) years old. 2. Subjects' weight within normal range according to normal values for Body Mass Index (1 8.0 to 30.0 kg/m2) with minimum of 50 kg weight. 3. Subjects with normal health as determined by personal medical history, cl...
Atorvastatin Calcium is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is an HMGCR inhibitor. The listed clinical program consists of Phase 1 bioequivalence studies in healthy adult volunteers, evaluating 40 mg and 80 mg tablet strengths under fasting and fed conditions.
Atorvastatin Calcium targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme. This target class places it among the statin class of small molecule agents.
Atorvastatin Calcium is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the Phase 1 bioequivalence studies listed for the 40 mg and 80 mg tablet strengths.
Atorvastatin Calcium is in Phase 1 development based on the listed program. All four recorded trials are Phase 1 bioequivalence studies, and all four are completed, with no active trials currently listed. The studies enrolled healthy volunteers rather than patients with a disclosed disease.
Four completed Phase 1 bioequivalence trials are listed: NCT01645449 and NCT01645423 for the 80 mg tablet under fasting and fed conditions, and NCT01645410 and NCT01645384 for the 40 mg tablet under fed and fasting conditions. Total enrollment across these studies was 294 healthy adult participants.