Status:

COMPLETED

Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Healthy

Eligibility:

MALE

20-44 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2009

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00920998

Start Date

March 1 2009

End Date

June 1 2009

Last Update

July 20 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kyushu, Japan

Effect of Food Intake on Pharmacokinetic Profiles of Z-338 | DecenTrialz