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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00867685 |
The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug.
This study will also study the effect of food on the tablet form of the drug.
Condition | Intervention | Phase |
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Healthy |
Drug: AZD2624 |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Crossover Assignment, Bio-availability Study |
Official Title: | A Phase I, Randomized, Open Label, 2-Way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of AZD2624 (Tablet Versus Liquid Suspension) Followed by an Additional Period to Assess the Food Effect on the Tablet |
Enrollment: | 16 |
Study Start Date: | March 2009 |
Study Completion Date: | April 2009 |
Arms | Assigned Interventions |
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Treatment A: Experimental
Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.
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Drug: AZD2624
Single dose of 40 mg AZD2624 liquid suspension, PO
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Treatment B: Experimental
Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.
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Drug: AZD2624
Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
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Treatment C: Experimental
Single oral dose of 40 mg (2x20mg tablets) in a fed state.
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Drug: AZD2624
Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States |
Principal Investigator: | Sylvan Hurewitz, MD | AstraZeneca Clinical Pharmacology Unit, US |
Responsible Party: | AstraZeneca Pharmaceuticals ( Mark Smith, MD, PhD, Senior Medical ScienceDirector Emerging Neuroscience ) |
Study ID Numbers: | D0970C00008 |
Study First Received: | March 18, 2009 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00867685 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Healthy Volunteers |
Healthy |