A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

Inclusion Criteria

• After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
• Male subjects are 18≤ age 6.2% at screening.
• Subjects with history of gastrointestinal operations.
• Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
• Subjects with past history of allergy to drugs.
• Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day -7) and administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day-14) and administration of study drug on the medication day (Day 1).
• Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day\_-7) and administration of study drug on medication day.
• Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
• Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
• Subjects have history of drug abuse or positive urine drug tests.
• Subjects with positive immunologic test results.
• Average amount of daily smoking>20 cigarettes.
• Subjects have taken other study drugs within 3 months (Day\_-90~Day 1) before medication.
• Subjects received lurasidone orally before.
• Subjects have history of blood donations of 400 mL within 3 months (Day\_-90~Day 1) before medication; 200 mL within 1 month (Day\_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day\_-14~Day 1) before medication.
• Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day\_-3) and before administration of study drug on medication day.
• Subjects can not tolerate venipuncture or have poor peripheral venous access.
• Subjects are unwilling to abstain from vigorous exercise from Day\_-1 until discharge.
• Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.