NCT01055834

A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)

A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 54 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone 3 mg	Group A Period I, Group B Period II: Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting \>=10 hours. Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug. Group B Period III: Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast. Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast \& the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration.
DRUG	Eszopiclone 1 mg	Group A Period II, Group B Period I: Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours. Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-01-26
• Last updated: 2013-02-12
• Results posted: 2013-02-12

Locations

1 site across 1 country: Japan