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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00721474 |
A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: Bosutinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects |
Estimated Enrollment: | 24 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Bosutinib fasting
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Drug: Bosutinib
Bosutinib fasting
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2: Experimental
Bosutinib fed
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Drug: Bosutinib
Bosutinib fed
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3160A4-1110 |
Study First Received: | July 22, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00721474 |
Health Authority: | United States: Food and Drug Administration |
Healthy |