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To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328

NCT ID: NCT00752830

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-10-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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AZD0328 Food Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

AZD0328 administration during fasting condition

Group Type EXPERIMENTAL

AZD0328

Intervention Type DRUG

Oral capsule, single dose

2

AZD0328 administration after food intake

Group Type EXPERIMENTAL

AZD0328

Intervention Type DRUG

Oral capsule, single dose

Interventions

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AZD0328

Oral capsule, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male Caucasian subjects.
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
* Signed informed consent form

Exclusion Criteria

* History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
* Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D, Södertälje, Sweden

Principal Investigators

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Didier Meulien, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje, Sweden

Gabriella Samuelsson Palmgren, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden

Locations

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Research Site

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EUdract NO 2008-003691-22

Identifier Type: -

Identifier Source: secondary_id

D0190C00009

Identifier Type: -

Identifier Source: org_study_id