Effect of Food Intake on Pharmacokinetic Profiles of Z-338
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers|
- Pharmacokinetics of Z-338 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: 1. Z-338
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
Other Name: YM443
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.