To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: AZD0328
- Registration Number
- NCT00752830
- Lead Sponsor
- AstraZeneca
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD0328 AZD0328 administration during fasting condition 2 AZD0328 AZD0328 administration after food intake
- Primary Outcome Measures
Name Time Method PK variables Several PK samples during the study days
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) During the whole treatment period
Trial Locations
- Locations (1)
Research Site
🇸🇪Lund, Sweden