Phase 4
N=76
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00917579 ↗Enrolled (actual)
76
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity) — 18.3206; 19.2583 ng•hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atorvastatin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity) |
18.3206; 19.2583 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
15.7382; 16.5452 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
2.6594; 2.8086 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) |
1.000; 0.5000 | — |
| SECONDARY Plasma Elimination Half-life (t1/2) |
10.39; 10.78 | — |
Summary
• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT00917579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.