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NCT07722728
A Study to Investigate Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 84
Sponsor: Bostal Drug Delivery Co., Ltd
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.
Eligibility Criteria
Inclusion Criteria:
1. Participant and/or their legally acceptable representative (LAR) must sign an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study as described in Section 10.1.3 and in this protocol and is willing to participate in the study.
2. Male or female participant with age of 18-65 years (both inclusive) at the time of signing the informed consent.
3. Participant has a body mass index (BMI) within the range 18.50 to 30.00 kg/m2 (inclusive).
4. Participant diagnosed with schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria.
5. Participant with a Clinical Global Impression-Severity of Illness (CGI-S) Score of ≤ 4 at screening.
6. Participant with Positive and Negative syndrome-scale (PANSS) total score ≤75 at screening.
7. Schizophrenic participants who are clinically stable on their current antipsychotic medication other than cariprazine, for a duration of at least 8 weeks prior to screening.
Note: Participants must NOT be taking \> 1 antipsychotic medication for their disease.
8. Participant who has previously received and tolerated oral cariprazine 3 mg or higher dose (no discontinuations due to AEs attributable to cariprazine).
9. Contraceptive use by participant or participant's partner(s) should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4: Contraceptive and Barrier Guidance.
OR
* Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \
Source: ClinicalTrials.gov (NCT07722728). StuddyBuddy aggregates publicly available trial information.