Study of Cariprazine Capsules 6 mg in Schizophrenia or Bipolar disorder I patients.
- Conditions
- Other schizophrenia,
- Registration Number
- CTRI/2018/09/015741
- Lead Sponsor
- APL Research Center
- Brief Summary
This is an open-label, randomized, three-treatment, four-sequence,two-period, cross-over, multiple dose, steady state, clinical bioequivalencestudy of two different formulations of Cariprazine Capsules 6 mg of AurobindoPharma 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 capsules6 mg.
Patients will be titrated upwards with VRAYLAR (Cariprazine)capsules 1.5 mg on day -38, 3 mg on day -37, 4.5 mg on day -36, and 6 mg on day-35 onwards clinically stabilized for at least 04 weeks. Patients with bipolardisorder I will be given Lithium carbonate 600 to 900 mg tablets once or twicedaily as per the Investigator discretion. Patients will be given Alprazolam or Nitrazepam or Lorazepam as andwhen required as per the Investigator discretion for Schizophrenia or Bipolar disorder I patients.
The study will be planned to investigate bioequivalence of AurobindoPharma’s two Test formulations with Reference formulation (T1 Vs R and T2 Vs R)so, the study will be divided into two groups each with 10 patients to comparebioequivalence of T1 with R and other T2 with R.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
- 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 OR 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.
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 Investigator’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, Parkinson’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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax-ss: Maximum concentration over the steady state dosing interval Venous blood samples 4 mL will be withdrawn within 5 minutes prior to dosing on Day 1, 2, 3 and 4 Period I and 6, 7 and 8 Period II to confirm steady state condition | Venous blood samples 4 mL will be withdrawn on Day 4 and 8 at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post drug administration. | The blood will be collected in a pre-labeled vacutainer tubes containing K2EDTA AUC0-τ: Area under the blood concentration – time curve over the steady state dosing interval. Venous blood samples 4 mL will be withdrawn within 5 minutes prior to dosing on Day 1, 2, 3 and 4 Period I and 6, 7 and 8 Period II to confirm steady state condition | Venous blood samples 4 mL will be withdrawn on Day 4 and 8 at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post drug administration. | The blood will be collected in a pre-labeled vacutainer tubes containing K2EDTA
- Secondary Outcome Measures
Name Time Method Cmin-ss: Minimum concentration over the steady state dosing interval. Cavg-ss: Average concentration over the steady state dosing interval.
Trial Locations
- Locations (1)
Divyam Hospital
🇮🇳Surat, GUJARAT, India
Divyam Hospital🇮🇳Surat, GUJARAT, IndiaDr Timir Kumar Chandrakant ShahPrincipal investigator9825137443drtcshah@gmail.com