NCT02220712

A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	OPC-14597 IMD	Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-08-20
• Last updated: 2021-01-25
• Results posted: 2021-01-25

Locations

5 sites across 1 country: Japan