Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

Summary

This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation \[CV\]%) of approximately 35%.

Timeline

Start

2011-02

Primary completion

2011-04

Completion

2011-06

Drugs

Indications