Bioequivalence Study Of Pediatric Appropriate Formulation
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Atorvastatin (Drug); Atorvastatin pediatric appropriate formulation (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing
to the 80 mg commercial atorvastatin calcium tablet formulation.
Clinical Details
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 design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
Secondary outcome: 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.
Detailed description:
Determination of Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, New Haven, Connecticut 06511, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2008
Ending date: April 2009
Last updated: February 12, 2009
|
