Pure Global AI
NCT06036108Recruiting

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Otsuka Pharmaceutical Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
OPC-34712FUM/ Brexpiprazole fumarate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Otsuka Pharmaceutical Co., Ltd.
Location
Saga-shi, Japan
Timeline & enrollment
Phase
Phase 1
Start date
Oct 03, 2023
End date
Jan 01, 2025
Enrollment
50 participants
Primary outcome

Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state,Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state

Summary

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole
 QW formulation.

ICD-10 classifications
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06036108
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06036108 through Pure Global AI's free database. This Phase 1 trial is sponsored by Otsuka Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Schizophrenia. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.