A clinical trial intended to compare two formulations of Clozapine in patients with Schizophrenia or Schizoaffective Disorder
- Conditions
- Health Condition 1: F25- Schizoaffective disordersHealth Condition 2: F20- Schizophrenia
- Registration Number
- CTRI/2018/02/012062
- Lead Sponsor
- Alembic Pharmaceuticals Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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 <100 mm Hg or >=140 mm Hg, diastolic BP <60
mm Hg or >=90 mm Hg) or heart rate ( <60 bpm or >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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A pharmacokinetic study to prove bioequivalence of Clozapine TabletsTimepoint: Day 10, total 14 venous blood samples (04 mL each) <br/ ><br>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, <br/ ><br>10.0, 12.0 hours post morning dose
- Secondary Outcome Measures
Name Time Method Monitor safety of the patientsTimepoint: day 1 to day 10 in each period <br/ ><br>2, 4, 6& 8 hours (± 30 <br/ ><br>minutes) post morning dose on Day 01and Day 10 in each period