Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

Official Title: “An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet In Healthy Subjects”

• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • A single 10 mg dose of marketed 10 mg atorvastatin tablets
• Drug: Atorvastatin
  • A single 10 mg dose of new formulation of 10 mg atorvastatin

Arms, Groups and Cohorts in this Clinical Trial

• Other: Reference
  • 10 mg atorvastatin
• Experimental: Test
  • New 10 mg atorvastatin tablet

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00917579

Study ID Number: A2581166

ClinicalTrials.gov Identifier: NCT00917579

Health Authority: United States: Food and Drug Administration

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