Health Condition 1: null- schizophrenic subjects
Conditions
Interventions
Intervention1: DICOMEX (Clozapine) 100
mg tablet of Laboratorios
Recalcine S.A., Chile: DICOMEX (Clozapine) 100
mg tablet twice daily for 10 days.Overall treatment period in the study is of 20 days i.
Sponsors
Laboratorios Recalcine SA
AZIDUS Laboratories Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to assess the steady state bioequivalence of DICOMEX (Clozapine) 100 mg tablet of Laboratorios Recalcine S.A., Chile and Clozaril® (Clozapine) 100 mg tablet of Novartis Pharmaceutical Corporation, East Hanover, New Jersey, USA in 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. Blood sampling during Day 10 and Day 20: 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
| Measure | Time frame |
|---|---|
| To monitor adverse events and ensure safety 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. 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 | — |
Countries
India
Contacts
Public ContactDr S Gunasakaran
Azidus Laboratories Ltd
Outcome results
None listed