SchizophreniaPhase 1NCT07266792
Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)
A Phase 1 study testing Brexpiprazole Film Coated Tablets and RXULTI film coated tablet in people with Schizophrenia, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brexpiprazole Film Coated Tablets and RXULTI film coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jun 2025to 7 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 3) 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).
- 4) 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).
- 5) Was able to communicate effectively with study personnel.
- 6) Was willing to provide written informed consent to participate in the study.
- 7) All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included:
- a) A physical examination (clinical examination) with no clinically significant finding.
- No additional tests and/or examinations were performed.
- All results were assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used was included in the study documentation.
Who cannot join
- 1) Had history of allergic responses to Brexpiprazole or other related drugs, or any of its formulation ingredients.
- 2) 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)].
- 3) 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.
- 4) Had history or presence of bronchial asthma.
- 5) Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
- 6) Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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- 7) 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).
- 8) Had history or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- 9) Had history of difficulty with donating blood or difficulty in accessibility of veins.
- 10) A positive hepatitis screen (includes subtypes B \& C).
- 11) A positive test result for HIV antibody.
- 12) 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.
- 13) 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.
- 14)Had history of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- 15) Intolerance to venipuncture
- 16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- 17) Institutionalized volunteer.
- 18) Used any prescribed medications within 14 days prior to the first dose of study medication.
- 19) Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- 20) Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- 21) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
- 22) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- 23) Volunteer with WBC and neutrophil count less than lower limit of normal range.
- 24) Volunteers with history of Psychosis, Suicidal thoughts and behavior or Stroke, Transient ischemic attack (TIA), Seizure or any other related medical condition.
- 25) Volunteers with QTc interval more than 450 ms on ECG measurement at the time of screening.
- 26) Sitting systolic blood pressure less than 110 mmHg or greater than 140 mmHg or sitting diastolic blood pressure less than 70 mmHg or greater than 90 mmHg and pulse rate less than 60 or greater than 100 beats per minute during screening.
- 27) Volunteer had a personal or family history of dystonic reactions to medications.
- 28)Had history of use of any neuroleptic drugs and illicit drugs.
- 29)Had history of Hyperglycemia.
- 30)Had history of Myocardial Infarction/ Ischaemic heart disease.
- 31)Had history of Venous Thromboembolism.
- 32)Had history of a known history of Extrapyramidal Symptoms (EPS).
- 33)Had history of Dementia and Tardive Dyskinesia.
- 34)Had history of Dysphagia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-period, Twotreatment, Two-sequence, Truncated, Crossover, Balanced, Single Dose Oral Bioequivalence Study.
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
- Being tested
- Brexpiprazole Film Coated Tablets, RXULTI film coated tablet
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexpiprazole Film Coated TabletsDrug
1 tablet of Brexpiprazole 4 mg Film Coated Tablets
RXULTI film coated tabletDrug
1 tablet of RXULTI 4 mg film coated tablet (Brexpiprazole)
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole Film Coated Tablets | Experimental | Brexpiprazole 4 mg Film Coated Tablets Receives: Drug: Brexpiprazole Film Coated Tablets; Drug: RXULTI film coated tablet |
| RXULTI film coated tablet | Active comparator | RXULTI 4 mg film coated tablet (Brexpiprazole) Receives: Drug: Brexpiprazole Film Coated Tablets; Drug: RXULTI film coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 hours
Secondary outcomes (1)
Time of the maximum measured plasma concentration (Tmax)
Descriptive Statistics
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start22 Jun 2025
- Primary completion4 Aug 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266792
- Sponsor's protocol ID
- C1B05603
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-period, Twotreatment, Two-sequence, Truncated, Crossover, Balanced, Single Dose Oral Bioequivalence Study.
- ClinicalTrials.gov ID
- NCT07266792
- Acronym / sponsor ID
- C1B05603
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole Film Coated Tablets | Experimental | Drug: Brexpiprazole Film Coated Tablets, Drug: RXULTI film coated tabletBrexpiprazole 4 mg Film Coated Tablets |
| RXULTI film coated tablet | Active comparator | Drug: Brexpiprazole Film Coated Tablets, Drug: RXULTI film coated tabletRXULTI 4 mg film coated tablet (Brexpiprazole) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (34 listed)
- 1) Had history of allergic responses to Brexpiprazole or other related drugs, or any of its formulation ingredients.
- 2) 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)].
- 3) 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.
- 4) Had history or presence of bronchial asthma.
- 5) Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brexpiprazole Film Coated Tablets1 tablet of Brexpiprazole 4 mg Film Coated Tablets | Drug | Brexpiprazole Film Coated Tablets, RXULTI film coated tablet |
| RXULTI film coated tablet1 tablet of RXULTI 4 mg film coated tablet (Brexpiprazole) | Drug | Brexpiprazole Film Coated Tablets, RXULTI film coated tablet |
Primary outcome
Maximum measured plasma concentration over the time span specified (Cmax)
Time frame: 72 hours
The 90% confidence interval of the relative mean (Geometric least square mean) of test to reference product for Ln-transformed Pharmacokinetic parameters Cmax
Area under the plasma concentration-time curve from time point to the 72 hours (AUC72)
Time frame: 72 hours
The 90% confidence interval of the relative mean (Geometric least square mean) of test to reference product for Ln-transformed Pharmacokinetic parameters AUC72
1 secondary outcome
Time of the maximum measured plasma concentration (Tmax)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brexpiprazole Film Coated Tablets and RXULTI film coated tablet in people with Schizophrenia, run by Humanis Saglık Anonim Sirketi at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measured plasma concentration over the time span specified (Cmax) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.