Study of Cariprazine Capsules 6 mg in Schizophrenia or Bipolar disorder I patients who are receiving Cariprazine capsules 6 mg as stable dose
- Conditions
- Health Condition 1: F208- Other schizophrenia
- Registration Number
- CTRI/2019/04/018793
- Lead Sponsor
- Aurobindo Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
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 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:
•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)
•Intrauterine Device (IUD)
•Progestin Implant (i.e. Implanon or its equivalent)
•Progestin injection or progestin oral contraceptive pill + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•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:
•Absolute neutrophil count (ANC) >=1500/μL
•Hemoglobin (Hb) >= 9 g/dL
•Platelets >= 100,000/ μL
•AST or ALT must be < 3 x ULN
•Total bilirubin < 1.5 x the institutional ULN
•Creatinine <= 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 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 at least 20 mm hg or more and / or a drop in diastolic blood pressure of at least 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. <br/ ><br>AUC0-Ï?: Area under the blood concentration â?? time curve over the steady state dosing interval.Timepoint: Venous blood samples 4 mL will be withdrawn 5 minutes prior to dosing on Day 12, 13 and 14 in Period I and Day 26, 27 and 28 Period II to confirm steady state condition. Day 1 predose sample will be collected to confirm that patients are on stable dose of Cariprazine. <br/ ><br>Venous blood samples 4 mL will be withdrawn on Day 14 and 28 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. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Cmin-ss: Minimum concentration over the steady state dosing interval. <br/ ><br>Cavg-ss: Average concentration over the steady state dosing interval. <br/ ><br>Percentage fluctuation: [Cmax-ss â?? Cmin-ss/ Cavg-ss] X 100 <br/ ><br>Tmax-ss: Time of maximum measured blood concentration over the steady state dosing interval. <br/ ><br>Cpd (pre-dose concentration)-Pre-dose concentrations determined before a dose at steady state. <br/ ><br>Swing: [Cmax-ss-Cmin-ss/ Cmin-ss] <br/ ><br>Timepoint: Venous blood samples 4 mL will be withdrawn 5 minutes prior to dosing on Day 12, 13 and 14 in Period I and Day 26, 27 and 28 Period II to confirm steady state condition. Day 1 predose sample will be collected to confirm that patients are on stable dose of Cariprazine. <br/ ><br>Venous blood samples 4 mL will be withdrawn on Day 14 and 28 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. <br/ ><br>