To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
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ClinicalTrials.gov Identifier: NCT00752830 |
Recruitment Status
:
Completed
First Posted
: September 15, 2008
Last Update Posted
: October 29, 2008
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Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
Tracking Information | |||||||
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First Submitted Date ICMJE | September 12, 2008 | ||||||
First Posted Date ICMJE | September 15, 2008 | ||||||
Last Update Posted Date | October 29, 2008 | ||||||
Study Start Date ICMJE | September 2008 | ||||||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
PK variables [ Time Frame: Several PK samples during the study days ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00752830 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) [ Time Frame: During the whole treatment period ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328 | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
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Condition ICMJE | Healthy | ||||||
Intervention ICMJE | Drug: AZD0328
Oral capsule, single dose |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
14 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | October 2008 | ||||||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 45 Years (Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Sweden | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00752830 | ||||||
Other Study ID Numbers ICMJE | D0190C00009 EUdract NO 2008-003691-22 |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden | ||||||
Study Sponsor ICMJE | AstraZeneca | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||
Verification Date | October 2008 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |