NCT03287505

Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.

Detailed description

In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug. In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole IM Depot	administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Timeline

• Start date: 2017-06-23
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2017-09-19
• Last updated: 2020-12-29

Locations

1 site across 1 country: China