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Effect of Food Intake on Pharmacokinetic Profiles of Z-338

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ClinicalTrials.gov Identifier: NCT00920998
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : July 20, 2009
Sponsor:
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Z-338 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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




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


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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

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

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

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