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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: AZD0328

Study type

Interventional

Funder types

Industry

Identifiers

NCT00752830
EUdract NO 2008-003691-22
D0190C00009

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

14 participants in 2 patient groups

1
Experimental group
Description:
AZD0328 administration during fasting condition
Treatment:
Drug: AZD0328
2
Experimental group
Description:
AZD0328 administration after food intake
Treatment:
Drug: AZD0328

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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