Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Official Title ICMJE
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
This study will test two different formulations. The results will be used to select formulation for phase 3.
Study Type ICMJE
Study Phase ICMJE
Study Design ICMJE
Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science
Hepatitis C Virus
Single dose of 750 mg PF-00868554 as a solution and tablets.
Other Name: pharmacokintics
Study Arms ICMJE
Intervention: Drug: Pharmacokinetics
* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Status ICMJE
Actual Enrollment ICMJE (submitted: July 6, 2009)
Original Estimated Enrollment ICMJE (submitted: March 12, 2009)
Actual Study Completion Date ICMJE
Actual Primary Completion Date
June 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Standard for healthy volunteers.
Sexes Eligible for Study:
18 Years to 45 Years (Adult)
Accepts Healthy Volunteers ICMJE
Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE
Removed Location Countries
NCT Number ICMJE
Other Study ID Numbers ICMJE
Has Data Monitoring Committee
U.S. FDA-regulated Product
IPD Sharing Statement ICMJE
Director, Clinical Trial Disclosure Group, Pfizer, Inc.