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

Eisai

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: Eszopiclone 1 mg; Drug: Eszopiclone 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055834

190-102

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Eszopiclone 3 mg tablet

Experimental group

Treatment:

Drug: Eszopiclone 3 mg

Eszopiclone 1 mg tablet

Experimental group

Treatment:

Drug: Eszopiclone 1 mg