An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Crossover, Single Dose Oral Bioequivalence Study of Cariprazine Capsules 1.5 mg (Test) of Optimus Pharma Limited, India and CARISPECTM (Cariprazine) Capsules 1.5 mg (Reference) of SUN Pharmaceutical Industries Ltd., in Healthy Adult Human Subjects under Fasting Condition

Optimus Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Volunteers meeting all the following inclusion criteria will be considered for enrolment in the study:
•1.Healthy human subjects aged between 18 years and 45 years (both inclusive).
•2.Having a Body Mass Index (BMI) between 18.50 and 24.99 kg/m2 (both inclusive).
•3.All volunteers must be judged by the Principal or Co-investigator or physician as normal and have no abnormal (clinically significant) findings during screening (medical history and examination, vitals, laboratory evaluations and ECG recording) within 28 days and chest X-Ray evaluation within 12 months prior to period-I dosing of study drug.
•4.Normal values in the assessment of depression using Depression Assessment Scale during each period check-in.
•5.Subjects are non-smokers and non-alcoholics.
•6.Subjects willing to adhere to protocol requirements and provide written informed consent.
•7.Females who are
•a.Childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine devices (IUD) or abstinence: or
•b.Post-menopausal for at least 1 year, or
•c.Surgically sterile (has undergone bilateral tubal ligation, bilateral; oophorectomy or hysterectomy).

•Volunteers will be excluded from participation in the study, if they meet any one of the
•following exclusion criteria
•1.Volunteer having known history of hypersensitivity to Cariprazine or to any component of the formulation.
•2.History or evidence of Depression, Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders.
•3.History of Irritable bowel syndrome with pain/discomfort as predominant symptom.
•4.History of constipation or chronic constipation and using related drugs.
•5.History or suspected with Intestinal obstruction due to tumor, hernia etc, as bowel obstruction disorder.
•6.History or evidence of COVID-19 during last 1 month
•7.History of loose stools in past 10 days.
•8.Any disease or condition which might compromise the hematopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system.
•9.Participation in any clinical research study or any bioavailability/bioequivalence study within 90 days prior to first dosing of the present study.
•10.Blood donation within 90 days prior to first dosing of the present study.
•11.History of difficulty in donating blood or difficulty in accessibility of veins.
•12.History or evidence of drug dependence.

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