Back to resultsA Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Eszopiclone 3 mg
Eszopiclone 1 mg
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
Eligibility Criteria
Inclusion criteria;
- 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
- Japanese healthy male adult volunteers
- Participants who are between 20 and 54 years of age at the time of obtaining written consent
- Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening
Exclusion criteria;
- Participants with a present illness or history of allergy to drug or food, or seasonal allergy
- Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
- 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
- Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Eszopiclone 3 mg tablet
Eszopiclone 1 mg tablet
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01055834
Brief Title
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Official Title
A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eszopiclone 3 mg tablet
Arm Type
Experimental
Arm Title
Eszopiclone 1 mg tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 3 mg
Intervention Description
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
Intervention Name(s)
Eszopiclone 1 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
Description
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Time Frame
immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Title
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Description
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Time Frame
immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Title
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Description
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Time Frame
immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Title
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Description
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Time Frame
immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria;
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
Japanese healthy male adult volunteers
Participants who are between 20 and 54 years of age at the time of obtaining written consent
Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening
Exclusion criteria;
Participants with a present illness or history of allergy to drug or food, or seasonal allergy
Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
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
Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenya Nakai
Organizational Affiliation
Japan Clinical Pharmacology, Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Sumida
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
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