Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1. Z-338

3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)

Group Type EXPERIMENTAL

Z-338

Intervention Type DRUG

oral

Interventions

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Z-338

oral

Intervention Type DRUG

Other Intervention Names

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YM443

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes