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Simvastatin · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Simvastatin | EXPERIMENTAL | Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd. |
| Zocor | ACTIVE_COMPARATOR | Zocor® 80 mg tablets of Merck \& Co. Inc., USA |
| Name | Type | Description |
|---|---|---|
| Simvastatin | DRUG | Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd |
Inclusion Criteria: * Subjects will provide written informed consent. * Subjects must be healthy adults within 18-45 years of age (inclusive) weighing at least 50 kg. * Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-we...
Simvastatin is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical trials. The specific medical conditions it aims to treat have not been disclosed.
Simvastatin targets HMGCR, which stands for 3-hydroxy-3-methylglutaryl-coenzyme A reductase. It acts as an inhibitor of this enzyme. By inhibiting HMGCR, simvastatin affects cholesterol synthesis, though its full therapeutic applications are still under investigation.
Simvastatin is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company publicly traded under the ticker symbol RDY. The company is responsible for its clinical development and potential commercialization.
Simvastatin is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The total enrollment across these trials was 116 participants.
Simvastatin has been tested in two completed Phase 1 trials: NCT01167933, a bioequivalence study under fed conditions with 44 participants, and NCT01167894, a bioequivalence study under fasting conditions with 72 participants. Both trials enrolled healthy volunteers.