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

Sponsor
Bostal Drug Delivery Co., Ltd
Study ID
NCT07722728
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 30 mg B2227 — DRUG
    Single-dose; Subcutaneous
  • 70 mg B2227 — DRUG
    Single-dose; Subcutaneous
  • 150 mg B2227 — DRUG
    Single-dose; Subcutaneous
  • Vraylar® 1.5 mg — DRUG
    Multiple-dose, Oral
  • Vraylar® 3.0 mg — DRUG
    Multiple-dose, Oral
  • Vraylar® 4.5 mg — DRUG
    Multiple-dose, Oral
  • Vraylar® 6.0 mg — DRUG
    Multiple-dose, Oral

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.5 mg Vraylar®
  • Experimental: 3.0 mg Vraylar®
  • Experimental: 4.5 mg Vraylar®
  • Experimental: 6 mg Vraylar®
  • Experimental: B2227 30 mg
  • Experimental: B2227 70 mg
  • Experimental: B2227 150 mg

Primary Outcome Measure

Cmax [ Time Frame: Pre-dose to 190 days post-dose ]

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