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Effect of Food Intake on Pharmacokinetic Profiles of Z-338

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920998
First Posted: June 16, 2009
Last Update Posted: July 20, 2009
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.
Information provided by:
Astellas Pharma Inc
  Purpose
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Condition Intervention Phase
Healthy Drug: Z-338 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of Z-338 [ Time Frame: 48 hours ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Z-338
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
Drug: Z-338
oral
Other Name: YM443

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920998


Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00920998     History of Changes
Other Study ID Numbers: 443-CL-503
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Astellas Pharma Inc:
Z-338
YM443
healthy volunteers