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Clinical Trial Summary

This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet doses administered either after an overnight fast or in combination with a standard high-fat meal in healthy subjects.


Clinical Trial Description

The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each subject�s study eligibility will be determined and baseline assessments will be conducted. During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization Phase will consist of 3 periods: administration of the first randomized dose (Treatment Period 1), baseline for the second randomized dose (Baseline Period 2), and administration of the second randomized dose (Treatment Period 2). ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02089412
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date February 2014
Completion date June 2014

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