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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00791817 |
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
Condition | Intervention | Phase |
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Healthy |
Drug: PG-760564 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects |
Enrollment: | 10 |
Study Start Date: | August 2005 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fasted Subjects
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Drug: PG-760564
200 mg capsule, single dose,fasted when dosed, duration is 4 days
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2: Experimental
Subjects on high fat meal
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Drug: PG-760564
200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
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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:
Responsible Party: | Procter and Gamble Pharmaceuticals ( William S Aronstein, PhD, MD ) |
Study ID Numbers: | 2005046B |
Study First Received: | November 13, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00791817 |
Health Authority: | United States: Food and Drug Administration |
pharmacokinetics study |
Healthy |