SCHIZOPHRENIA 1 (Disorder)Phase 1NCT07691190
Bioequivalence Study to Compare Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) Versus Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine)
A Phase 1 study testing Cariprazine Hard Capsules and Reagila® Hartkapseln (Hard Capsules) (Cariprazine) in people with SCHIZOPHRENIA 1 (Disorder), run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
Single dose oral bioequivalence study of Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in healthy adult human participants under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder)
- What is being tested?
- Cariprazine Hard Capsules and Reagila® Hartkapseln (Hard Capsules) (Cariprazine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 5 Mar 2026to 26 Jun 2026
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (â-HCG) pregnancy test performed within 28 days of the first dose of study medication. They must be using an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception include 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.
- Female will not be considered of child-bearing potential if one of then following is reported and documented on the medical history:
- Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. 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).
- Able to communicate effectively with study personnel.
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- Non-alcoholic, non-smoker and non-tobacco user (i.e. having no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior to study).
- Normal or clinically non-significant ECG recording during screening.
- Willing to provide written informed consent to participate in the study.
- All participants must be 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 will include:
- A physical examination (clinical examination) with no clinically significant finding.
- Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
- All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Who cannot join
- History of allergic responses to Cariprazine or other related drugs, or any of its formulation ingredients.
- Have 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 participants)].
- 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.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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- Use of 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).
- History or evidence of drug dependence.
- 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.
- Participant who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- Participant who have 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 is greater.
- History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- Intolerance to venipuncture
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant's participation in this study.
- Institutionalized participant.
- Use of any prescribed medications within 14 days prior to the first dose of study medication.
- Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- History of cardiovascular disease or a family history of QT prolongation.
- History of dementia related psychosis.
- Have a personal or family history of dystonic reactions to medications.
- Total WBC count and neutrophil percentage less than lower limit of normal range during screening.
- History of seizures or convulsions or epilepsy.
- History or presence of malignant neuroleptic syndrome.
- History of (or have a family history of) bipolar disorder or suicidal thoughts or actions, or any other psychiatric problems or dementia related psychosis.
- SGPT, SGOT value 1.1 times higher than upper limit of normal range during screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Oral Bioequivalence Study of Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in Healthy Adult Human Participants Under Fasting Conditions.
Single dose oral bioequivalence study of Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in healthy adult human participants under fasting conditions.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Being tested
- Cariprazine Hard Capsules, Reagila® Hartkapseln (Hard Capsules) (Cariprazine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cariprazine Hard CapsulesDrug
1 capsule of 1.5 mg Cariprazine hydrochloride
Reagila® Hartkapseln (Hard Capsules) (Cariprazine)Drug
1 capsule of 1.5 mg Cariprazine
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine Hard Capsules | Experimental | Cariprazine Hard Capsules (1.5 mg Cariprazine hydrochloride) Receives: Drug: Cariprazine Hard Capsules; Drug: Reagila® Hartkapseln (Hard Capsules) (Cariprazine) |
| Reagila® Hartkapseln (Hard Capsules) (Cariprazine) | Active comparator | Reagila® Hartkapseln (Hard Capsules) (1,5 mg Cariprazine) Receives: Drug: Cariprazine Hard Capsules; Drug: Reagila® Hartkapseln (Hard Capsules) (Cariprazine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration versus time curve calculated using the linear trapezoidal rule from the zero time point to the 72 hours (AUC72)
The statistical method for testing bioequivalence was based on the determination of the 90% confidence interval around the ratio of the Ln-transformed population means (Test/Reference) for the PK parameters AUC72
Measured: 72.00 hours
Maximum measured plasma concentration (Cmax)
The statistical method for testing bioequivalence was based on the determination of the 90% confidence interval around the ratio of the Ln- ransformed population means (Test/Reference) for the PK parameters Cmax
Measured: 72.00 hours
Secondary outcomes (1)
Time of the maximum measured plasma concentration (Tmax)
Descriptive Statistics
Measured: 72.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start5 Mar 2026
- Primary completion2 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies 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
- 32 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
- NCT07691190
- Sponsor's protocol ID
- C1B06283
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Oral Bioequivalence Study of Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in Healthy Adult Human Participants Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT07691190
- Acronym / sponsor ID
- C1B06283
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 8 Jul 2026 (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 Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in healthy adult human participants under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine Hard Capsules | Experimental | Drug: Cariprazine Hard Capsules, Drug: Reagila® Hartkapseln (Hard Capsules) (Cariprazine)Cariprazine Hard Capsules (1.5 mg Cariprazine hydrochloride) |
| Reagila® Hartkapseln (Hard Capsules) (Cariprazine) | Active comparator | Drug: Cariprazine Hard Capsules, Drug: Reagila® Hartkapseln (Hard Capsules) (Cariprazine)Reagila® Hartkapseln (Hard Capsules) (1,5 mg Cariprazine) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (â-HCG) pregnancy test performed within 28 days of the first dose of study medication. They must be using an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception include 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.
- 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).
- Able to communicate effectively with study personnel.
- Non-alcoholic, non-smoker and non-tobacco user (i.e. having no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior to study).
Key exclusion criteria (30 listed)
- History of allergic responses to Cariprazine or other related drugs, or any of its formulation ingredients.
- Have 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 participants)].
- 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.
- History or presence of bronchial asthma.
- Use of 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 |
|---|---|---|
| Cariprazine Hard Capsules1 capsule of 1.5 mg Cariprazine hydrochloride | Drug | Cariprazine Hard Capsules, Reagila® Hartkapseln (Hard Capsules) (Cariprazine) |
| Reagila® Hartkapseln (Hard Capsules) (Cariprazine)1 capsule of 1.5 mg Cariprazine | Drug | Cariprazine Hard Capsules, Reagila® Hartkapseln (Hard Capsules) (Cariprazine) |
Primary outcome
The area under the plasma concentration versus time curve calculated using the linear trapezoidal rule from the zero time point to the 72 hours (AUC72)
Time frame: 72.00 hours
The statistical method for testing bioequivalence was based on the determination of the 90% confidence interval around the ratio of the Ln-transformed population means (Test/Reference) for the PK parameters AUC72
Maximum measured plasma concentration (Cmax)
Time frame: 72.00 hours
The statistical method for testing bioequivalence was based on the determination of the 90% confidence interval around the ratio of the Ln- ransformed population means (Test/Reference) for the PK parameters Cmax
1 secondary outcome
Time of the maximum measured plasma concentration (Tmax)
Time frame: 72.00 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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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 Cariprazine Hard Capsules and Reagila® Hartkapseln (Hard Capsules) (Cariprazine) in people with SCHIZOPHRENIA 1 (Disorder), 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 13 inclusion and 30 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 8 Jul 2026. 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?
The area under the plasma concentration versus time curve calculated using the linear trapezoidal rule from the zero time point to the 72 hours (AUC72) (time frame: 72.00 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 8 Jul 2026.