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临床试验/CTRI/2018/09/015741
CTRI/2018/09/015741已完成1 期

An, Open-label, Randomized, Three-Treatment, Four-sequence, Two-period, Cross-over, Multiple dose, Steady state Clinical Bioequivalence Study of two different formulations of Cariprazine Capsules 6 mg of Aurobindo Pharma Limited, India (T1 and T2) with VRAYLAR (Cariprazine) Capsules 6mg of Allergan USA, Inc. Irvine, CA 92612, USA(Reference) in patients already receiving a stable dose of Cariprazine capsules 6 mg

APL Research Center0 个研究点目标入组 20 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Ba/be

入排标准

入选标准

  • •1.Male and female patient aged 18 to 65 Years (both inclusive) with body mass index between 18.5 to 30 kg/m2 (both inclusive)
  • •2.Patient already receiving stable dose of Cariprazine 6 mg once daily for at least 04 weeks before screening only
  • •3.Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features
  • •Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Schizophrenia
  • •4.Patient having adequate hematologic reserve at screening as per principal investigator assessment
  • •5.Patient having adequate and stable hepatic and renal function as per principal investigator assessment at screening only
  • •6.Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X-ray as per the discretion of Principal Investigator at screening only
  • •7.Patient and Legally Acceptable Representative had given consent after being advised of the nature and risks of the study
  • •8.Female patient of childbearing potential must have a negative serum pregnancy test
  • •9.Females must use acceptable and effective methods of contraception such as the following:
  • •9.1 Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1)
  • •9.2 Intrauterine Device (IUD)
  • •9.3 Progestin Implant (i.e. Implanon or its equivalent)
  • •9.4 Progestin injection or progestin oral contraceptive pill + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
  • •9.5 Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
  • •9.6 Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) during the study and till 60 days post dose
  • •10.Patient having normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI) at screening only
  • •11.Patient having laboratory values as follows:
  • •11.1 Absolute neutrophil count (ANC) greater than or equal to 1500/μL
  • •11.2 Hemoglobin (Hb) greater than or equal to 9 g/dL.
  • •11.3 Platelets greater than or equal to 100,000/ μL
  • •11.4 AST or ALT must be less than 3 x ULN
  • •11.5 Total bilirubin less than 1.5 x the institutional ULN¬¬
  • •11.6 Creatinine less than or equal to 1.5 x ULN

排除标准

  • •1.Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose range
  • •2.Active suicidal or homicidal intent (as documented by informants or in the Investigatorâ??s opinion) or a prior suicide or homicide attempt in the past 2 years
  • •3.At imminent risk of injuring self or others or causing significant damage to property, as judged by the Investigator
  • •4.Documented disease of the central nervous system that could interfere with the study assessments, including but not limited to stroke, tumor, Parkinsonâ??s disease, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who had suffered a traumatic brain injury resulting in significant impairment
  • •5.Patient with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease
  • •6.Patient with known history of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm hg or more and / or a drop in diastolic blood pressure of 10 mm Hg or more on standing)
  • •7.Patient with cataracts
  • •8.Current or past history of tardive dyskinesia or neuroleptic malignant syndrome
  • •9.Patient found to be positive for HIV and/or HBsAg and/or HCV at preliminary screening
  • •10.Patient with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression
  • •11.Patient is unable to communicate with the investigator
  • •12.Patients with history of allergic reactions to Cariprazine or chemically related psychotropic drugs
  • •13.Patient is smoker or alcoholic
  • •14.Patient had history of difficulty with donating blood or difficulty in accessibility of veins
  • •15.Patient consumed grape fruit/mosumbi/sweet lime juice within the 48 hours prior to study check-in
  • •16.Female patient who is pregnant or currently breast-feeding
  • •17.Females of child bearing potential unwilling to use acceptable contraception throughout the trial and for 14 days after the last dose of study drug
  • •18.Patient participation in another clinical trial within the preceding 90 days of study starts

研究者

发起方
APL Research Center

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