A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Eszopiclone 3 mg; Eszopiclone 1 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.; 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 MeSH terms: Eszopiclone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 20 Years
Maximum age: 54 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)

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.
    

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