Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as pravastatin sodium
pravastatin · 4 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Pravastatin | EXPERIMENTAL | Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period |
| Pravachol® | ACTIVE_COMPARATOR | Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period |
| Pravastatin fast | EXPERIMENTAL | Test product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods |
| Name | Type | Description |
|---|---|---|
| Pravastatin sodium 80 mg tablets | DRUG | 1 x 80 mg |
| Pravachol® 80 mg tablets | DRUG | 1 x 80 mg |
| Pravastatin | DRUG | 80 mg Tablet |
| pravastatin sodium | DRUG | 40 mg Tablet |
| Pravachol® | DRUG | 40 mg tablet |
Inclusion Criteria: * Healthy, non-smoking male and female subjects, 18 years of age or older. * BMI greater than or equal to 19 and less than or equal to 30. * Negative for: * HIV. * Hepatitis B surface antigen and Hepatitis C antibody. * Using drugs of abuse test (marijuana, amphetamines, ...
Pravastatin is a small molecule HMGCR inhibitor developed by Teva Pharmaceutical Industries Limited (ticker TEVA). It is being studied in Phase 1 clinical development, with four completed trials conducted in healthy adult volunteers. The trials evaluated pravastatin sodium tablets at 40 mg and 80 mg doses under fasting, non-fasting, and food challenge conditions.
Pravastatin targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme. This molecular target and inhibitor class are the basis for how pravastatin is designed to work as a small molecule therapeutic.
Pravastatin is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical development program for this asset.
Pravastatin is in Phase 1 clinical development. All four of its listed trials are Phase 1 studies and all four are completed, with no active trials currently ongoing. The program has enrolled a total of 158 participants across these studies.
Pravastatin has been evaluated in four completed Phase 1 trials: NCT00834847, a food challenge study of 40 mg tablets; NCT00834379, a fasting bioavailability study of 40 mg tablets; NCT00830258, a fasting study of 80 mg tablets; and NCT00829309, a non-fasting study of 80 mg tablets in healthy subjects.
Yes, pravastatin is also known as pravastatin sodium, and it is referenced as pravastatin sodium 80 mg tablets in some trial listings. These names refer to the same drug asset developed by Teva Pharmaceutical Industries Limited under the ticker TEVA.