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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00861458 |
This study will test two different formulations. The results will be used to select formulation for phase 3.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C Virus |
Drug: Pharmacokinetics |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Single Group Assignment, Bio-availability Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PF-00868554: Experimental |
Drug: Pharmacokinetics
Single dose of 750 mg PF-00868554 as a solution and tablets.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Belgium | |
Pfizer Investigational Site | Recruiting |
Bruxelles, Belgium, 1070 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8121010 |
Study First Received: | March 12, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00861458 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Malnutrition Hepatitis, Viral, Human Healthy Hepatitis C |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C |