Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)

NCT07266792 | Completed Phase 1

• 1 other identifier: C1B05603
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Single dose oral bioequivalence study of Brexpiprazole 4 mg Film Coated Tablets and RXULTI® (Brexpiprazole) 4 mg film-coated tablets in healthy adult human subjects under fasting conditions.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Maximum measured plasma concentration over the time span specified (Cmax)

  The 90% confidence interval of the relative mean (Geometric least square mean) of test to reference product for Ln-transformed Pharmacokinetic parameters Cmax

  72 hours

• Area under the plasma concentration-time curve from time point to the 72 hours (AUC72)

  The 90% confidence interval of the relative mean (Geometric least square mean) of test to reference product for Ln-transformed Pharmacokinetic parameters AUC72

  72 hours

Secondary Outcomes (1)

• Time of the maximum measured plasma concentration (Tmax)

  72 hours

Study Arms (2)

Brexpiprazole Film Coated Tablets

EXPERIMENTAL

Brexpiprazole 4 mg Film Coated Tablets

Drug: Brexpiprazole Film Coated Tablets; Drug: RXULTI film coated tablet

RXULTI film coated tablet

ACTIVE COMPARATOR

RXULTI 4 mg film coated tablet (Brexpiprazole)

Drug: Brexpiprazole Film Coated Tablets; Drug: RXULTI film coated tablet

Interventions

Brexpiprazole Film Coated Tablets DRUG

1 tablet of Brexpiprazole 4 mg Film Coated Tablets

Brexpiprazole Film Coated Tablets; RXULTI film coated tablet

RXULTI film coated tablet DRUG

1 tablet of RXULTI 4 mg film coated tablet (Brexpiprazole)

Brexpiprazole Film Coated Tablets; RXULTI film coated tablet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 45 to 65 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female.
• A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They must use an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception included the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
• iii. Surgical sterilization or
• iv. Practicing sexual abstinence throughout the course of the study.
• B. Female were not considered of child-bearing potential if one of the following was reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or
• ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or
• iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• iv. Total hysterectomy and an absence of bleeding for at least 3 months.
• \) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
• \) Non-smokers and non-tobacco user (i.e. had no past history of smoking and tobacco consumed for at least one year prior to study).
• \) Was able to communicate effectively with study personnel.

You may not qualify if:

• \) Had history of allergic responses to Brexpiprazole or other related drugs, or any of its formulation ingredients.
• \) Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• \) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
• \) Had history or presence of bronchial asthma.
• \) Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• \) Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• \) Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• \) Had history or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• \) Had history of difficulty with donating blood or difficulty in accessibility of veins.
• \) A positive hepatitis screen (includes subtypes B \& C).
• \) A positive test result for HIV antibody.
• \) Volunteer who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• \) Volunteer who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• )Had history of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• \) Intolerance to venipuncture

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 382210, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 5, 2025
• Study Start: June 22, 2025
• Primary Completion: August 4, 2025
• Study Completion: October 7, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

IN (1)