Health Condition 1: F25- Schizoaffective disorders Health Condition 2: F20- Schizophrenia
Conditions
Interventions
Intervention1: Clozapine Tablets, USP 100 mg of Alembic Pharmaceuticals Limited, India: Dose: Multiples of 100 mg
Frequency: Twice daily
Route of administration: Oral
Duration: 10 days
Control Interve
Sponsors
Alembic Pharmaceuticals Limited India
Eligibility
Inclusion criteria
Inclusion criteria: Sex: Males or non-pregnant, non-lactating females. - In case of females of child bearing potential, a negative pregnancy test is required to participate in the study. - Acceptable forms of contraception include the following: a. 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 b. Barrier methods containing or used in conjunction with a spermicidal agent, or c. Surgical sterilization, or d. Practicing sexual abstinence throughout the course of the study - Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history: a. spontaneous amenorrhea for at least one year, or b. 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml, or c. at least 6 weeks postsurgical following bilateral oophorectomy with or without hysterectomy - Diagnosed with Schizophrenia or schizoaffective disorder according to the DSM-V criteria. -All patients should have a Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 18. BMI values should be rounded to the nearest integer. (e.g. 35.4 rounds down to 35. - Currently stable on a regimen consisting of multiples of Clozapine 100 mg twice daily for at least 3 months - Smoking Status: Non-smokers - 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.
Exclusion criteria
Exclusion criteria: Patients must not be enrolled in the study if they meet any one of the following criteria: 1) Institutionalized subjects 2) Social Habits: - A history of alcohol or drug dependence by DSM-V 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 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 anticholinergic medications - Use of any medication known to induce or inhibit CYP450 enzyme activity (CYP1A2, CYP 3A and CYP2D6) within 28 days prior to the initial dose of study medication (Refer Appendix II). 4) Diseases: - History of or presence of 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. PROTOCOL # CRL061516 Protocol Version 3.0 dated 05 May 2017 Confidential Page 27 of 67 - 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, hypokalemia, prolonged QT interval, abnormal ECG 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) Abnormal blood pressure (systolic BP =140 mm Hg, diastolic BP mm Hg or >=90 mm Hg) or heart rate ( 100 bpm) 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) History of multiple syncopal episodes 15) A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease 16) Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease 17) History of epilepsy or risk for seizures 18) A total white blood cell count below 4000/mL or an absolute neutrophil count below 2000/mL 19) A history of granulocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A pharmacokinetic study to prove bioequivalence of Clozapine TabletsTimepoint: Day 10, total 14 venous blood samples (04 mL each) will be collected at 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 hours post morning dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitor safety of the patientsTimepoint: day 1 to day 10 in each period 2, 4, 6& 8 hours (± 30 minutes) post morning dose on Day 01and Day 10 in each period | — |
Countries
India
Contacts
Public ContactMr Vidhushekhar Mishra
Cliantha Research Limited
Outcome results
None listed