Status:
COMPLETED
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00917644
Start Date
July 1 2008
End Date
September 1 2008
Last Update
February 21 2021
Active Locations (1)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33169