Bioequivalence Study to Compare Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochlorid… (NCT07691190) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) Versus Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine)
India32 participantsStarted 2026-03-05
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
. 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:
Exclusion criteria
. 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.
. 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).