Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2008

Interventions

  • 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

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

Clinical Trial Outcome Measures

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
    • AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng*hr/mL). Pharmacokinetic (PK) parameters derived from subject’s concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
  • 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
    • AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject’s concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
  • 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
    • Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.

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
    • Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject’s concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
  • 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
    • t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject’s concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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