Bio Equivalence study comparing two formulations of Clozapine in patients with Schizophrenia or Schizoaffective Disorder.
- Conditions
- Health Condition 1: null- Schizophrenia or Schizoaffective Disorder
- Registration Number
- CTRI/2015/07/005980
- Lead Sponsor
- Cadila healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.Age: 18 - 65 years.
2.Sex: Males or non-pregnant, non-lactating females.
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.
7.Subjects will be otherwise healthy as determined by the investigator in reference to physical examination, medical history and routine hematologic and biochemical tests.
1.Institutionalized subjects
2.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
3.Medications
Use of any prescription or over-the-counter (OTC) medications including vitamins and herbal products that would be expected to alter Clozapine pharmacokinetics within fourteen (14) days prior to the initial dose of study medication.
Use of any hormonal contraceptives or hormone replacement therapy within 2 months prior to study medication dosing.
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 within 28 days prior to the initial dose of study medication
4.Diseases:
History of any significant cardiovascular, hepatic, renal, pulmonary, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal disease, or malignancies, unless deemed not clinically significant by the Principal Investigator or Co-investigator.
History of diabetes, severe allergic reaction
Acute illness at the time of either the pre-study medical evaluation or dosing.
5.History of allergy or adverse reactions to Clozapine or chemically related psychotropic drugs
6. Acute psychotic exacerbations within 3 months of start of study.
7.History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator.
8.Patients with hypomagnesemia (defined as serum magnesium < 0.7 mEq/L), hypokalemia (defined as serum or plasma potassium < 3.5 mM or mEq/L), prolonged QT interval or bradycardia during screening.
9.History or known case of Organic Brain Disease.
10.History of Clozapine related agranulocytosis.
11.Electroconvulsive therapy (ECT) within 30 days prior to dosing.
12.Clinically significant blood pressure or heart rate measurements during screening
13.Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
14.Abnormal ECG: QTc > 450 msec in male subject or QTc > 470 msec in female subjects at screening
15. Heart rate less than 50 beats/min
16.History of multiple syncopal episodes
17.A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
18.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
19.History of epilepsy or risk for seizures
20.A total white blood cell count below 4000/mL or an absolute neutrophil count below 2000/mL
21.A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
22.Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension
23.Concurrent use of other drugs known to suppress bone marrow function
24.Expected change
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method