Back to resultsBioequivalence Study On Pediatric Appropriate Formulation
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Lipitor
Atorvastatin pediatric formulation
Sponsored by
About this trial
This is an interventional other trial for Hypercholesterolemia focused on measuring Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy male and/or female subjects
- Mass Index (BMI) of approximately 18 to 30 kg/m2
Exclusion Criteria:
- Any condition possibly affecting drug absorption
- A positive urine drug screening
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Reference
Test
Arm Description
Commercial 10 mg Lipitor formulation tablet
Atorvastatin pediatric formulation
Outcomes
Primary Outcome Measures
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
Secondary Outcome Measures
Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.
Full Information
NCT ID
NCT00777517
First Posted
October 20, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00777517
Brief Title
Bioequivalence Study On Pediatric Appropriate Formulation
Official Title
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A Pediatric Appropriate Formulation To A 10 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cardiovascular Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference
Arm Type
Other
Arm Description
Commercial 10 mg Lipitor formulation tablet
Arm Title
Test
Arm Type
Other
Arm Description
Atorvastatin pediatric formulation
Intervention Type
Drug
Intervention Name(s)
Lipitor
Other Intervention Name(s)
Atorvastatin
Intervention Description
A single dose of 10 mg Lipitor tablet
Intervention Type
Drug
Intervention Name(s)
Atorvastatin pediatric formulation
Intervention Description
A single dose of 10 mg atorvastatin pediatric formulation
Primary Outcome Measure Information:
Title
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and/or female subjects
Mass Index (BMI) of approximately 18 to 30 kg/m2
Exclusion Criteria:
Any condition possibly affecting drug absorption
A positive urine drug screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581174&StudyName=Bioequivalence%20Study%20On%20Pediatric%20Appropriate%20Formulation
Description
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Bioequivalence Study On Pediatric Appropriate Formulation
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