Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Z-338

• Registration Number: NCT00920998
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-16
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. Z-338	Z-338	3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Z-338	48 hours