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

Completed · Phase 4

Conditions studied: Hypercholesterolemia

In brief

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

Key facts

Study ID

NCT00917644

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

76

Starts

2008-07-01

Expected to finish

2008-09-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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