Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00830258 | Pravastatin Sodium 80 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Apr 1, 2005 | Apr 1, 2005 | Aug 19, 2024 | 1 | Canada |
| NCT00834379 | Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 58 | — | — | Sep 1, 2000 | Sep 1, 2000 | Oct 8, 2020 | 1 | Canada |
| NCT00834847 | Pravastatin Sodium 40 mg Tablets Food Challenge Study | PHASE1 | COMPLETED | 24 | — | — | Aug 1, 2000 | Sep 1, 2000 | Jan 9, 2020 | 1 | Canada |
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, ...