Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pravachol · 3 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 sodium | DRUG | 40 mg Tablet |
| Pravachol® | DRUG | 40 mg tablet |
| pravastatin | 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, ...
Pravachol is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials evaluating pravastatin sodium tablets under fasting and fed conditions. The drug is being developed by Teva Pharmaceutical Industries Limited (TEVA).
Pravachol is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.
Pravachol is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. All three completed trials were Phase 1 studies.
Pravachol has three completed Phase 1 trials: NCT00830258 (pravastatin sodium 80 mg tablets under fasting conditions), NCT00834379 (bioavailability of 40 mg tablets under fasting conditions), and NCT00834847 (40 mg tablets food challenge study). All trials enrolled healthy volunteers in Canada.
Pravachol is a brand name for pravastatin sodium. The clinical trials listed under Pravachol evaluate pravastatin sodium tablets at doses of 40 mg and 80 mg, confirming that Pravachol and pravastatin refer to the same active ingredient.