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NCT00861458 Clinical Trial

Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

Hepatitis C Virus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00861458
Other study ID # A8121010
Secondary ID
Status Completed
Phase Phase 1
First received March 12, 2009
Last updated July 6, 2009
Start date April 2009
Est. completion date June 2009

Study information
Verified date July 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will test two different formulations. The results will be used to select formulation for phase 3.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy volunteers.

Exclusion Criteria:

- Standard for healthy volunteers.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Pharmacokinetics
Single dose of 750 mg PF-00868554 as a solution and tablets.

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC inf, Cmax 2 days No
Secondary Adverse events 2 days No
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