PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration

This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.

To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks

Inclusion Criteria:

1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.

Exclusion Criteria:

1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;
3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

Other protocol-defined inclusion and exclusion criteria may apply.