Effect of Food Intake on Pharmacokinetic Profiles of Z-338

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920998
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : July 20, 2009
Information provided by:
Astellas Pharma Inc

June 15, 2009
June 16, 2009
July 20, 2009
March 2009
June 2009   (Final data collection date for primary outcome measure)
Pharmacokinetics of Z-338 [ Time Frame: 48 hours ]
Same as current
Complete list of historical versions of study NCT00920998 on Archive Site
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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
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.
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.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Drug: Z-338
Other Name: YM443
Experimental: 1. Z-338
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
Intervention: Drug: Z-338
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 44 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Director, Astellas Pharma, Inc
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP