Official Title: “An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet In Healthy Subjects”

To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • A single 80 mg dose of marketed 80 mg atorvastatin tablets
• Genetic: Atorvastatin
  • A single dose of new formulation of 80 mg atorvastatin tablets

Arms, Groups and Cohorts in this Clinical Trial

• Other: Reference
  • 80 mg atorvastatin tablets
• Experimental: Test
  • New 80 mg atorvastatin tablets

Primary Measures

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
  • Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
    Safety Issue?: No
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
  • Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
    Safety Issue?: No
• Maximum Observed Plasma Concentration (Cmax)
  • Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
    Safety Issue?: No

Secondary Measures

• Time to Reach Maximum Plasma Concentration (Tmax)
  • Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
    Safety Issue?: No
• Plasma Elimination Half-life (t1/2)
  • Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00917644

Study ID Number: A2581167

ClinicalTrials.gov Identifier: NCT00917644

Health Authority: United States: Food and Drug Administration

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