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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00752830
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : October 29, 2008
Information provided by:

September 12, 2008
September 15, 2008
October 29, 2008
September 2008
October 2008   (Final data collection date for primary outcome measure)
PK variables [ Time Frame: Several PK samples during the study days ]
Same as current
Complete list of historical versions of study NCT00752830 on Archive Site
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) [ Time Frame: During the whole treatment period ]
Same as current
Not Provided
Not Provided
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
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
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Drug: AZD0328
Oral capsule, single dose
  • Experimental: 1
    AZD0328 administration during fasting condition
    Intervention: Drug: AZD0328
  • Experimental: 2
    AZD0328 administration after food intake
    Intervention: Drug: AZD0328
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
EUdract NO 2008-003691-22
Not Provided
Not Provided
Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden
Not Provided
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
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP