Status:
COMPLETED
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
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
Eligibility Criteria
Inclusion
- 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);
- 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
- Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
- 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.
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03285503
Start Date
August 17 2018
End Date
October 14 2019
Last Update
July 10 2020
Active Locations (1)
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1
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100088