Back to resultsBioequivalence Study Of Pediatric Appropriate Formulation
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin pediatric appropriate 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 volunteers
- 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 80 mg atorvastatin tablet
Pediatric appropriate atorvastatin 40mg 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
NCT00758004
First Posted
September 22, 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
NCT00758004
Brief Title
Bioequivalence Study Of Pediatric Appropriate Formulation
Official Title
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 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
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 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 pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 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 80 mg atorvastatin tablet
Arm Title
Test
Arm Type
Other
Arm Description
Pediatric appropriate atorvastatin 40mg formulation
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
A single dose of 80 mg atrovastatin tablet
Intervention Type
Drug
Intervention Name(s)
Atorvastatin pediatric appropriate formulation
Other Intervention Name(s)
Atorvastatin
Intervention Description
A single dose of pediatric appropriate atorvastatin 80 mg 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 volunteers
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
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581175&StudyName=Bioequivalence%20Study%20Of%20Pediatric%20Appropriate%20Formulation
Description
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Bioequivalence Study Of Pediatric Appropriate Formulation
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