Status:
COMPLETED
Bioequivalence Study Of Pediatric Appropriate Formulation
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.
Detailed Description
Determination of Bioequivalence
Eligibility Criteria
Inclusion
- Healthy male and/or female volunteers
- Mass Index (BMI) of approximately 18 to 30 kg/m2
Exclusion
- Any condition possibly affecting drug absorption
- A positive urine drug screening
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00758004
Start Date
October 1 2008
End Date
March 1 2009
Last Update
February 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511