Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lipitor · 1 trial · 1 indication
| 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
Lipitor is used for hypercholesterolemia, a condition of high cholesterol levels in the blood. It is being developed as a small molecule therapeutic in the metabolic therapeutic area. The drug is currently in clinical development for this indication.
Lipitor is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug for the treatment of hypercholesterolemia.
Lipitor is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing development is focused on evaluating its safety and pharmacokinetics in patients with hypercholesterolemia.
Lipitor has one completed clinical trial, identified as NCT00777517. This was a Phase 1 bioequivalence study on a pediatric appropriate formulation, conducted in Singapore with 76 participants. The trial enrolled healthy volunteers aged 18 years and older.
Lipitor is a brand name for the drug atorvastatin. The clinical trial NCT00777517 evaluates a pediatric appropriate formulation of this medication. The drug is being studied for its bioequivalence in treating hypercholesterolemia.