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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00777517 | Bioequivalence Study On Pediatric Appropriate Formulation | PHASE1 | COMPLETED | 76 | — | — | Nov 1, 2008 | Feb 1, 2009 | Feb 18, 2021 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Reference | OTHER | Commercial 10 mg Lipitor formulation tablet |
| Test | OTHER | Atorvastatin pediatric formulation |
| Name | Type | Description |
|---|---|---|
| Lipitor | DRUG | A single dose of 10 mg Lipitor tablet |
| Atorvastatin pediatric formulation | DRUG | A single dose of 10 mg atorvastatin pediatric formulation |
Inclusion Criteria: * Healthy male and/or female subjects * Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: * Any condition possibly affecting drug absorption * A positive urine drug screening