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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00752830

Enrollment

Registered

2008-09-15

Start date

2008-09-30

Completion date

2008-10-31

Last updated

2008-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD0328, Food Effect

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.

Interventions

DRUGAZD0328

Oral capsule, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
PK variables	Several PK samples during the study days

Secondary

Measure	Time frame
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)	During the whole treatment period

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026