Status:
COMPLETED
Bioequivalence Study On 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 a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
Detailed Description
Determination of Bioequivalence
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects
- 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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00777517
Start Date
November 1 2008
End Date
February 1 2009
Last Update
February 18 2021
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770