CTRI/2019/12/022239尚未招募未知
A Multicentric Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Crossover, Steady State, Comparative Bioavailability Study Of Clozapine Extended Release Capsule 200 mg Once Daily (Test Drug, Intas Pharmaceuticals Limited, India) with Clozaril® 100 mg Tablets Twice Daily (Reference Drug, Novartis Pharmaceuticals Corporation, USA) after Multiple Dose Administration in Adult Schizophrenic Patients Under Fasting Conditions.
试验速览
- 阶段
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- 尚未招募
研究概览
简要总结
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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 Patients 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 atleast six weeks).
- •4. Male and female patients between 18 and 60 years of age (both inclusive).
- •5. Male patients with weight >= 50 kg and female patients with weight >= 45 kg.
- •6. 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.
- •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 patients safety by participating in the study or study objectives in investigators 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 randomization.
- •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.
- •Note: Elimination half-life of the study drug should be taken in to consideration for inclusion of the patient in the study.
- •16. A known case of or positive test for 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.
研究者
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