Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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%.