PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Study Details
Study Description
Brief Summary
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 400 mg group Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally). |
Drug: Aripiprazole IM Depot
administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum Plasma Concentration (Cmax) [up to 24 weeks]
To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
- time of maximum observed plasma concentration (tmax) [up to 24 week]
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
- AUC672h [up to 24 weeks]
To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
- Apparent clearance after extravascular administration [up to 24 weeks]
To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
Secondary Outcome Measures
- Adverse Events [up to 24 weeks]
Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
- Vital Signs [up to 24 weeks]
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
- Laboratory Examination [up to 24 weeks]
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)
Other Outcome Measures
- Positive and Negative Symptoms Scale (PANSS) [up to 24 weeks]
To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
-
Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
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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:
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Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
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Subjects who are alcoholomania or independent of drug, or have drug abuse history;
-
Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;
Other protocol-defined inclusion and exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anding Hospital of Capital Medical University | Beijing | Beijing | China | 100088 |
Sponsors and Collaborators
- Otsuka Beijing Research Institute
Investigators
- Principal Investigator: Tao Jiang, Master, Beijing Anding Hospital of Capital Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 031-403-00049