Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atorvastatin pediatric appropriate formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Reference | OTHER | Commercial 80 mg atorvastatin tablet |
| Test | OTHER | Pediatric appropriate atorvastatin 40mg formulation |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | A single dose of 80 mg atrovastatin tablet |
| Atorvastatin pediatric appropriate formulation | DRUG | A single dose of pediatric appropriate atorvastatin 80 mg formulation |
Inclusion Criteria: * Healthy male and/or female volunteers * Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: * Any condition possibly affecting drug absorption * A positive urine drug screening