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A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects

2014-08-27 03:16:26 | BioPortfolio

Summary

The purpose of this study is to investigate and evaluate the bioequivalence and food effect in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Description

This is a single center, randomized, open-label, cross-over (2 arms, 3 periods) study to investigate and evaluate the bioequivalence (42 subjects) and food effect (14 subjects) in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Insomnia

Intervention

Eszopiclone, Eszopiclone

Location

Sumida
Tokyo
Japan

Status

Completed

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:26-0400

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