Effect of Food Intake on Pharmacokinetic Profiles of Z-338

A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920998

Enrollment

Registered

2009-06-16

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2009-07-20

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

Conditions

Healthy

Keywords

Z-338, YM443, healthy volunteers

Brief summary

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Detailed description

The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Interventions

DRUGZ-338

oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 44 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subject * Body weight: 50.0 - 80.0 kg * BMI: 17.6 - 26.4

Exclusion criteria

* Receiving an investigational new drug within 120 days of the study * Receiving medical treatment drugs within 7 days of the study * Blood donation before the study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of Z-338	48 hours

Countries

Japan

Outcome results

None listed

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