A clinical trial intended to compare Bioequivalence of two formulations of Clozapine in patients with Schizophrenia or Schizoaffective Disorder.
- Conditions
- Health Condition 1: null- Schizophrenia or Schizoaffective Disorder
- Registration Number
- CTRI/2017/01/007744
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
) Age:18 - 65 years.
2) Gendre: Males or non-pregnant, non-lactating females.
a) In case of females of child bearing potential, a negative pregnancy test is required to participate in the study.
b) Acceptable forms of contraception include the following:
i. Taking oral contraceptives or Intrauterine device in place for at least 2 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
iii. Surgical sterilization, or
iv. Practicing sexual abstinence throughout the course of the study
c) Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months
3) Diagnosed with Schizophrenia or schizoaffective disorder according to the DSM-IV criteria.
4) Currently stable on a regimen consisting of multiples of Clozapine 100 mg twice daily for at least 3 months
5) Smoking Status: Non-smokers to moderate-smokers ( < 20 cigarettes per day)
6) The patient and LAR must demonstrate adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate.
1) Patients who are morbidly obese (defined as having a body mass index [BMI] greater than 40; BMI weight [kg]height [m2]).
2) Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
3) Acute psychotic exacerbations within 3 months of start of study.
4) History or known case of Organic Brain Disease.
5) History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator.
6) History of epilepsy or risk for seizures
7) A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
8) History of multiple syncopal episodes
9) A history of severe hepatic impairment, drug induced leukopenia or neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
10) History of any significant pulmonary, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal disease, or malignancies, unless deemed not clinically significant by the Principal Investigator or Co-investigator.
11) History of uncontrolled diabetes , severe allergic reaction
12) Acute illness at the time of either the pre-study medical evaluation or dosing.
13) Patients have a known history of phenylketonuria.
14) A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Clozapine
15) Social Habits:
• A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
• Ingestion of any alcoholic food or beverages within the 48 hours prior to the initial dose of study medication
• Positive tests for drug or alcohol abuse at screening or check-in of any period
16) Medications, Procedures and others:
• Use of any prescription or over-the-counter (OTC) medications including vitamins and herbal products that would be expected to alter Clozapine pharmacokinetics within 30 days prior to the initial dose of study medication. They can be allowed depending on Principal Investigatorâ??s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
• A depot injection or implant of any drug within 2 months prior to administration of study medication.
• Use of any medication known to induce or inhibit CYP450 enzyme activity (CYP1A2, CYP 3A and CYP2D6) within 30 days prior to the initial dose of study medication (Refer Appendix II). They can be allowed depending on Principal Investigatorâ??s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
• Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension
• Concurrent use of other drugs known to suppress bone marrow function
• Electroconvulsive therapy (ECT) within 30 days prior to dosing.
• Consumption of grapefruit, grapefruit-like, or grapefruit containing products within 7 days of drug administration.
17) History of allergy or adverse reactions to Clozapine or chemically related psychotropic drugs
18) Patie
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the PK profile of Clozapine and FazacloTimepoint: Day 1- Blood samples 2 x 4 mL pre-dose sample in each period. <br/ ><br>Day 07 to Day 10, a pre-dose blood sample of 04 mL <br/ ><br>will be collected <br/ ><br>Day 10, total 19 venous blood samples (04 mL each) <br/ ><br>will be collected at <br/ ><br>0.25, 0.5, 1.0, 1.333, 1.667, 2.0, 2.333, 2.667, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0 hours post dose <br/ ><br>
- Secondary Outcome Measures
Name Time Method Comparision the safety profile of Clozapine and FazacloTimepoint: Safety Evaluation: <br/ ><br>(Vital sign, Physical Examination, lab parameter check)