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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Reference

80 mg atorvastatin tablets

Group Type OTHER

Atorvastatin

Intervention Type DRUG

A single 80 mg dose of marketed 80 mg atorvastatin tablets

Test

New 80 mg atorvastatin tablets

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type GENETIC

A single dose of new formulation of 80 mg atorvastatin tablets

Interventions

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Atorvastatin

A single 80 mg dose of marketed 80 mg atorvastatin tablets

Intervention Type DRUG

Atorvastatin

A single dose of new formulation of 80 mg atorvastatin tablets

Intervention Type GENETIC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes