Bioequivalence Study to Compare Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) Versus Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine)

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.

B. Female will not be considered of child-bearing potential if one of then following is reported and documented on the medical history:

i. 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.
• 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.

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).
• 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.