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A Study to Investigate Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia

NCT07722728 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-07-23

No results posted yet for this study

Summary

The study is to evaluate the pharmacokinetic profile of B2227 Extended-Release Injectable Suspension against Vraylar® Cariprazine capsules of AbbVie Inc. in participants with schizophrenia.

Conditions

Interventions

DRUG

30 mg B2227

Single-dose; Subcutaneous

DRUG

70 mg B2227

Single-dose; Subcutaneous

DRUG

150 mg B2227

Single-dose; Subcutaneous

DRUG

Vraylar® 1.5 mg

Multiple-dose, Oral

DRUG

Vraylar® 3.0 mg

Multiple-dose, Oral

DRUG

Vraylar® 4.5 mg

Multiple-dose, Oral

DRUG

Vraylar® 6.0 mg

Multiple-dose, Oral

Sponsors & Collaborators

  • Bostal Drug Delivery Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722728 on ClinicalTrials.gov