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

NCT ID: NCT01055834

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eszopiclone 3 mg tablet

Group Type: EXPERIMENTAL

Eszopiclone 3 mg

Intervention Type: DRUG

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.

Eszopiclone 1 mg tablet

Group Type: EXPERIMENTAL

Eszopiclone 1 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will

2. Japanese healthy male adult volunteers

3. Participants who are between 20 and 54 years of age at the time of obtaining written consent

4. Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening

Exclusion Criteria

1. Participants with a present illness or history of allergy to drug or food, or seasonal allergy

2. Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation

3. Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions

4. Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening

5. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen

6. Participants who underwent blood transfusion within 12 weeks prior to, those whose 400 mL or more of whole blood was collected within 12 weeks prior to, or those whose 200 mL or more of whole blood was collected within 4 week prior to study drug administration

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenya Nakai

Role: STUDY_DIRECTOR

Japan Clinical Pharmacology, Eisai Co., Ltd.

Locations

Sumida City, Tokyo, Japan

Countries

Japan

Other Identifiers

190-102

Identifier Type: -

Identifier Source: org_study_id