CTRI/2022/04/041819已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Cariprazine Capsules 1.5 mg of Optimus Pharma Limited, India and CARISPECTM (Cariprazine) Capsules 1.5 mg of SUN Pharmaceutical Industries Ltd., in healthy, adult, human subjects under fasting Condition.
研究概览
简要总结
An open label, balanced, randomized, two treatment, two sequence, twoperiod, crossover, single dose, oral bioequivalence study in healthy adult human subjects under fasting condition. The active ingredient of Cariprazine is cariprazine HCl, an atypical antipsychotic. The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
To compare the rate and extent of absorption of Cariprazine Capsules 1.5 mg of Optimus Pharma Limited, India and CARISPECTM (Cariprazine) Capsules 1.5 mg of SUN Pharmaceutical Industries Ltd., in healthy, adult, human subjects under fasting Condition.
时间窗: NIL
次要结局
- To monitor the subject’s safety and tolerability of single dose oral dose of(investigational products (IPs).)
研究者
研究点 (1)
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