Conditions: Schizophrenia
Keywords: pharmacokinetic lurasidone single dose
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: yes

Brief summary:
To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Detailed description:
Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

Arms:
arm 1: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. arm 2: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. arm 3: single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

Interventions: intervention 1: 20mg lurasidone intervention 2: 40mg lurasidone intervention 3: 80mg lurasidone intervention 4: placebo
Intervention descriptions: intervention 1: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 2: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 3: single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. intervention 4: None

Protocol document: