CTRI/2024/02/062981进行中（未招募）不适用
A Multicentric, Open-label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Multiple dose, Steady state Bioequivalence Study of Cariprazine Hard Capsules 6 mg of Rontis Hellas S.A, Greece (Test) with Reagila® 6 mg Hard Capsules of Gedeon Richter Plc. (Reference) in Schizophrenia or Bipolar I Disorder patients already receiving a stable dose of Cariprazine capsules 6 mg.
Rontis Hellas S.A4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年3月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- To determine the steady state bioequivalence (compare the rate and extent of absorption) of Cariprazine Hard Capsules 6 mg (Test) and Reagila® 6mg Hard Capsules of Gedeon Richter Plc. (Reference) in patients already receiving a stable dose of Cariprazine Capsules 6 mg.
研究概览
简要总结
To determine the steady state bioequivalence of Cariprazine Hard Capsules 6 mg (Test) and Reagila® 6mg Hard Capsules of Gedeon Richter Plc. (Reference) in patients already receiving a stable dose of Cariprazine Capsules 6 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate and provide consent themself (or) by the Legally acceptable representative.
- •Meet the criteria for Schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) OR those for bipolar I disorder without psychotic features in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
- •Receiving a stable dose of Cariprazine 6 mg once daily for at least 04 weeks prior to screening
- •With no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X ray
- •Female patients must have negative Urine pregnancy test result at screening.
- •If of childbearing potential, they must be practicing an acceptable method of birth control during the study and till 60 days post last dose such as • Intrauterine Device (IUD) abstinence or double barrier contraception • Have been postmenopausal for at least 01 year if less than 1 year then use acceptable contraceptive measures listed above or • Be surgically sterile (bilateral tubal ligation bilateral,tubectomy oophorectomy,or hysterectomy has been performed on the subject)
- •Male patients willing to follow an approved birth control method (a double barrier method) for the duration of the study as judged by the investigator and till 60 days post study such as condom with spermicide or condom with diaphragm,or abstinence.
- •Subject should not donate sperm for 60 days.
排除标准
- •History of Hypersensitivity to Cariprazine or any of the excipients (Brilliant blue FCF,Allura red AC,Titanium dioxide,Gelatin, Shellac,Black iron oxide,Propylene glycol and Potassium hydroxide)
- •With any psychiatric illness (other than Schizophrenia or bipolar disorder), neurological disorders including neurologic malignant syndrome,major depressive disorder,organic mental disorder,severe tardive dyskinesia,Parkinson’s disease,history or presence of epilepsy or risk of seizures,history of multiple syncopal episodes or stroke
- •Who had undergone exacerbation of Schizophrenia and ECT (Electro Convulsive therapy) within the two months before the date of Screening.
- •Hospitalization for an exacerbation of Schizophrenia within the 2 months before the date of screening.
- •With significant clinically relevant endocrinal,cerebrovascular, pulmonary,haematological, immunological and cardiovascular disease (Ex heart failure, history of myocardial infarction or ischemia, conduction abnormalities,cardiomyopathy, myocarditis),cerebrovascular disease, or conditions that predispose the patient to hypotension (Ex dehydration, hypovolemia,and treatment with antihypertensive medications).
- •Could lead to safety risk.
- •Who answered yes to question 4 (active suicidal ideation with some intent to act,without a specific plan) or question 5 (active suicidal ideation with a specific plan and intent) for the time period of past 12 months from screening on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (CSSRS)
- •History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval (QTc ge 440 ms).
- •History of clinically significant eye disorders like increased intra ocular pressure or reduced visual acuity and cataracts.
- •Female subjects with a positive pregnancy test result or who are breastfeeding.
- •With a positive test result for HIV, HBsAg or HCV
- •Who are taking medicines used to treat Tuberculosis, Bacterial or Fungal infection, Cushing s syndrome, depression, epilepsy, seizures, heart disease, Sleepiness or Pulmonary Arterial Hypertension (PAH)
- •Use any of the following medications within the 04 weeks before enrolment: • Strong inhibitors of CYP3A4 • Strong inducers of CYP3A4 • Drugs associated with QT prolongation.
- •â€¢ Any other drug that the investigator considers might adversely affect the wellbeing of the patient or influence the outcome of the study.
- •History of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin dependent diabetes mellitus), or gastrointestinal disease
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Participated in a clinical trial or donated blood within the 90 days prior to enrolment.
- •Who had major surgery within the 2 months prior to study entry, or who have not recovered from prior major surgery.
- •History of venous thromboembolism or conditions that predispose the risk of embolism.
- •Medical or surgical condition that might interfere with the absorption, metabolism or excretion of Cariprazine.
- •With clinically significant hyperprolactinemia or Prolactinoma.
- •With known hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption.
- •Any condition or abnormal baseline findings that, in the Investigator judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
结局指标
主要结局
To determine the steady state bioequivalence (compare the rate and extent of absorption) of Cariprazine Hard Capsules 6 mg (Test) and Reagila® 6mg Hard Capsules of Gedeon Richter Plc. (Reference) in patients already receiving a stable dose of Cariprazine Capsules 6 mg.
时间窗: Day 12, Day 13 and Day 14 and Day 26, Day 27 and Day 28
次要结局
- To assess the safety and tolerability of Cariprazine Hard Capsules 6 mg in patients with Schizophrenia or Bipolar I disorder, as assessed by reported adverse events, laboratory and clinical investigations and vital signs.(Day 12, Day 13 and Day 14 and Day 26, Day 27 and Day 28)
研究者
Dr. Vishnupriya Bommareddy
QPS Bioserve India Pvt Ltd
研究点 (4)
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