CTRI/2019/10/021798尚未招募未知
A MULTICENTRIC OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO PERIOD, TWO-SEQUENCE, CROSSOVER, STEADY STATE, DOSAGE STRENGTH EQUIVALENCE STUDY OF CLOZAPINE EXTENDED RELEASE CAPSULE 25 MG (LOWEST STRENGTH, 25 MG X 8 CAPSULES) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) WITH CLOZAPINE EXTENDED RELEASE CAPSULE 200 MG (HIGHEST STRENGTH) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) AFTER MULTIPLE DOSE ADMINISTRATION IN ADULT SCHIZOPHRENIC PATIENTS UNDER FASTING CONDITIONS.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Written informed consent for participation in the study by the patient and Patient Legally Acceptable Representative (LAR).
- •2. Patient has a documented clinical diagnosis of schizophrenia according to DSM 5 at least six months prior to screening.
- •3. Patients have a diagnosis of treatment-resistant schizophrenia (Treatment resistance is the failure to respond to two or more antipsychotic medications given in therapeutic dose for at least six weeks).
- •4. Male and female patients between 18 and 60 years of age (both inclusive).
- •5. Non-smokers and non-tobacco users in any form.
- •Note: For this study, non-smoker/non-tobacco user is defined as a person who has not smoked /consumed tobacco in any form within last six months prior to screening visit.
- •6. Male patients with weight >= 50 kg and female patients with weight >= 45 kg.
- •7. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening-including medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recording, ophthalmic examination, etc. which is
- •likely to adversely affect patient safety by participating in the study or study objectives in investigator opinion.
- •8. The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
- •9. Patients have been on a daily stable dose of 200 mg clozapine formulation for at least 3 month prior to screening visit.
- •10. Able to comply with study procedures in the opinion of the investigator.
- •11. In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study
- •drug. Cessation of birth control after this point should be discussed with a responsible physician.
- •12. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including
- •oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence,
- •use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days
- •after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
排除标准
- •1. Patient with known hypersensitivity/ intolerance to clozapine or any other component of the drug.
- •2. Clinically symptomatic orthostatic hypotension.
- •Note: Orthostatic hypotension is defined as a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more on standing.
- •3. Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
- •4. Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beat per minute at screening and Day 0.
- •5. Concurrent primary psychiatric or neurological diagnosis (except schizophrenia), including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsons disease.
- •6. An absolute neutrophil count <1500/μL performed at the screening and a day prior to dosing.
- •7. A history of granulocytopenia, agranulocytosis or myeloproliferative
- •disorders (drug-induced or idiopathic).
- •8. A history of epilepsy, paralytic ileus, or multiple syncopal episodes.
- •9. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine.
- •10. Known case of poor metabolizer individuals with reduced activity of cytochrome P450 enzymes particularly, 1A2, 2D6 and 3A4.
- •11. Ingestion of any restricted medication at any time within 07 days before the first study drug administration.
- •12. Positive tests for drug or alcohol abuse at screening and baseline.
- •13. A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders V (DSM 5) criteria during the 6-month period immediately prior to screening.
- •14. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study medication or during the study.
- •Note: In case the blood loss is less than or equal to 200 ml; Patient may be dosed 60 days after blood loss.
- •15. Receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medication or during the study.
- •16. History or active presence of HIV infection or hepatitis B or HCV.
- •17. Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
- •18. Psychosis judged to be the direct physiological effect of an abused medication or substance.
- •19. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
- •20. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •21. Patients with the following cardiac conditions are excluded:
- •a. Recent myocardial infarction ( <12 months)
- •b. QTc prolongation (screening electrocardiogram with QTc >450 msec)
- •c. History of QTc prolongation or using concomitant medications which prolong QTc interval.
- •d. First-degree heart block with PR interval > 0.22 seconds.
- •e. Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia
- •f. Uncompensated congestive heart failure, myocarditis, cardiomyopathy
- •g. Complete left bundle branch block.
- •22. Presence of narrow angle glaucoma assessed by tonometry.
- •23. Patient with hypokalemia and / or hypomagnesemia.
- •24. Patients with unco
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