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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00752830 |
The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: AZD0328 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects |
Enrollment: | 14 |
Study Start Date: | September 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AZD0328 administration during fasting condition
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Drug: AZD0328
Oral capsule, single dose
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2: Experimental
AZD0328 administration after food intake
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Drug: AZD0328
Oral capsule, single dose
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Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Research Site | |
Lund, Sweden |
Study Director: | Didier Meulien, MD | AstraZeneca R&D Södertälje, Sweden |
Principal Investigator: | Gabriella Samuelsson Palmgren, MD | AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden |
Responsible Party: | AstraZeneca R&D, Södertälje, Sweden ( Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition ) |
Study ID Numbers: | D0190C00009, EUdract NO 2008-003691-22 |
Study First Received: | September 12, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00752830 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
AZD0328 Food Effect |
Healthy |