Comparative oral bioequivalence study of DICOMEX (Clozapine) 100 mg tablet ofLaboratorios Recalcine S.A., Chile and ClozarilÂ® (Clozapine) 100 mg tablet of NovartisPharmaceutical Corporatio

Not Applicable

Conditions: Health Condition 1: null- schizophrenic subjects

Registration Number: CTRI/2015/10/006303

Lead Sponsor: aboratorios Recalcine SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

Male and/or non-pregnant female patients more than 18 years of age

Female volunteer willing to practice an acceptable method of birth control as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence throughout the duration of the study; or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Schizophrenic patients receiving stable dose of Clozapine (100 mg b.i.d.) for at least 3

months.

Patients at least 18-years of age or older, and the patientâ??s body mass index (BMI) must be

within 18.5 â?? 30.0 (Kg/m2

Subjects who have no evidence of underlying disease (except Schizophrenia) during

screening medical history and whose physical examination is performed within 21 days

prior to commencement of the study.

Subjects whose screening laboratory values are within normal limits or considered by the

clinical Investigator/Co-Investigator to be of no clinical significance.

Exclusion Criteria

A history of allergic reactions to clozapine or other chemically related psychotropic drugs

Concurrent primary psychiatric or neurological diagnosis, including organic mental

disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease

A total white blood cell count below 4000/mL, or an absolute neutrophil count below

2000/mL

A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)

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)

Concurrent use of antihypertensive medication or any medication that might predispose to

orthostatic hypotension

A medical or surgical condition that might interfere with the absorption, metabolism, or

excretion of clozapine

A history of epilepsy or risk for seizures

Concurrent use of other drugs known to suppress bone marrow function

Expected changes in concomitant medications during the period of study

Positive tests for drug or alcohol abuse at screening or baseline

A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental

Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry.

History of multiple syncopal episodes

Use of following drugs as concurrent therapy:

(Phenytoin, nicotine, rifampin, Cimetidine, caffeine, erythromycin, ciprofloxacin,

fluvoxamine, fluoxetine, paroxetine, sertraline, selective serotonin reuptake inhibitors,benzodiazepine, phenothiazines, carbamazepine, propafenone, flecainide, encainide,

quinidine).

Smoking or consumption of tobacco products.

A medical or surgical condition that might interfere with the absorption, metabolism, or

excretion of clozapine.

Female subject who is pregnant, lactating or likely to become pregnant or have a positive

pregnancy test at screening and prior to study.

Positive result to HIV, HCV, RPR and HBsAg.

Use of enzyme-modifying drugs (like Barbiturates, Gresiofulvin etc.) in the previous 30days before day 1 of this study.

Abnormal 12 lead ECG, X-ray.

Patients have a history of narrow angle glaucoma.

Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.

Participation in another clinical trial within the preceding 90 days of study starts.

Subjects who have:

Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.

Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor

deviations (2 - 4 mm Hg) at check-in may be acceptable at the discretion of the clinical

investigator.

Pulse rate below 60/min. or above 100/min.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the steady state bioequivalence of <br/ ><br>DICOMEX (Clozapine) 100 mg tablet of Laboratorios Recalcine <br/ ><br>S.A., Chile and ClozarilÂ® (Clozapine) 100 mg tablet of Novartis <br/ ><br>Pharmaceutical Corporation, East Hanover, New Jersey, USA in <br/ ><br>36 schizophrenic subjects under fasting conditionsTimepoint: In each of the two study periods, 24 blood samples will be collected. The pre-dose sampling will be done on Day 7 â?? Day 10 and Day 17 â?? Day 20. The pre-dose blood sample 3 ml will be collected within 5 minutes prior to dosing. <br/ ><br>Blood sampling during Day 10 and Day 20: <br/ ><br>The post-dose blood samples (1 x 3 ml each) will be collected at 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00,03.50, 04.00, 05.00, 06.00, 08.00, 10.00 and 12.00 hrs

Secondary Outcome Measures

Name	Time	Method
To monitor adverse events and ensure safety <br/ ><br>of the subjectsTimepoint: Physical examination, vital parameter assessment and wellbeing assessment will be performed to all study subjects during subject check-out, to ensure safety of the study subjects. <br/ ><br>Apart from this, at the end of the study, post study evaluation will be performed for biochemical, hematological given in Annexure I will be evaluated, to ensure that no subject is having abnormal laboratory parameters