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

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.

Inclusion Criteria:

1. Age: 18 to 55 years old, both inclusive.

2. 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.

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. Able to communicate effectively with study personnel.

5. 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).

6. Normal or clinically non-significant ECG recording during screening.

7. Willing to provide written informed consent to participate in the study.

8. 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:

   1. 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:

1. History of allergic responses to Cariprazine or other related drugs, or any of its formulation ingredients.
2. 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)].
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. History or presence of bronchial asthma.
5. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
6. Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
7. 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).
8. History or evidence of drug dependence.
9. 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. 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.
13. 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.
14. 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 participant's participation in this study.
17. Institutionalized participant.
18. Use of any prescribed medications within 14 days prior to the first dose of study medication.
19. Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
20. Use of 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 caffeinecontaining sodas, colas, etc.), recreational drugs 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. History of cardiovascular disease or a family history of QT prolongation.
24. History of dementia related psychosis.
25. Have a personal or family history of dystonic reactions to medications.
26. Total WBC count and neutrophil percentage less than lower limit of normal range during screening.
27. History of seizures or convulsions or epilepsy.
28. History or presence of malignant neuroleptic syndrome.
29. History of (or have a family history of) bipolar disorder or suicidal thoughts or actions, or any other psychiatric problems or dementia related psychosis.
30. SGPT, SGOT value 1.1 times higher than upper limit of normal range during screening.