CTRI/2016/06/007015尚未招募未知
A multi-center, open-label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, steady-state bioequivalence study of Clozapine Tablets USP 100 mg of Micro Labs Limited, India with CLOZARIL® (Clozapine) 100 mg Tablets of Novartis Pharma Corp., USA in fasting condition among subjects with schizophrenia already stabilized under Clozapine treatment
Micro Labs Limited India0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
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
- •A subject fulfilling all the following criteria will be included in the present study:
- •1. Subjects and his/her legally acceptable representatives (LAR) â??
- •a. Willing to provide written informed consent for participation in the study;
- •b. Having ability to comprehend the nature and purpose of the study;
- •c. Willing to be available for the entire study period and to comply protocol requirements.
- •2. Disease population and treatment condition â??
- •a. Subjects with documented clinical diagnosis of Schizophrenia as per DSM-IV-TR Criteria;
- •b. Subjects with Treatment-resistant Schizophrenia defined as failure to respond to two or more antipsychotic medications given in therapeutic dose for >= six weeks);
- •c. Currently stable on a regimen consisting of single or multiples of Clozapine tablets 100mg twice daily for at least 3 months.
- •3. Age of 18-65 years (both inclusive);
- •4. Body mass index (BMI) in the range of 18.50 â?? 29.99 kg/m2 (both inclusive);
- •5. Non-smoker and willing to abstain from chewing any tobacco containing product during housing period in clinical facility;
- •6. Willing to abstain from alcohol or alcoholic products, xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), and grapefruit or its juice during housing period in clinical facility;
- •7. Adequate hematological reserves, particularly â??
- •a. A total WBC count >= 4000/µL;
- •b. ANC >=2000/mL;
- •8. Clinically non-significant serum electrolytes (sodium, potassium, magnesium and chloride);
- •9. With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
- •10. With a normal or clinically non-significant 12-lead ECG (including QTc interval <=500 milliseconds);
- •11. In case of female subjects:
- •a. Negative urine pregnancy test during screening and, negative serum β-HCG test at baseline visits and at check-in for housing during each study period;
- •b. Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse, or using acceptable methods of birth control during the study (Acceptable birth control methods include barrier methods such as diaphragm/condom with spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed).
排除标准
- •A subject fulfilling any one of the following criteria will be excluded from the study:
- •1. Institutionalized subjects;
- •2. A history of allergic or hypersensitive reactions to clozapine or other chemically related psychotropic drugs or to any of the excipients of formulation which in the opinion of an investigator, would compromise the safety of the subject or the study;
- •3. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease;
- •4. Acute psychotic exacerbations within 3 months of start of study;
- •5. Elder subjects with dementia-related psychosis;
- •6. History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator;
- •7. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic);
- •8. Concurrent use of other drugs known to suppress bone marrow function;
- •9. 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);
- •10. History of multiple syncopal episodes;
- •11. Concurrent use of antihypertensive medication or any medication that might pre¬dispose to orthostatic hypotension;
- •12. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine;
- •13. A history of epilepsy or risk for seizures;
- •14. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction, which in the opinion of an investigator, would compromise the safety of the subject or the study;
- •15. Expected changes in concomitant medications during the study periods;
- •16. Expected incompliance with outpatient medications;
- •17. A history of alcohol or drug dependence by DSM-IV-TR criteria during the 6-month period immediately prior to study entry;
- •18. Positive alcohol breath or urine drug of abuse tests during baseline visits, or at check-in for housing during each study period;
- •19. Positive test for Human Immunovirus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibodies;
- •20. In case of female subjects:
- •a. Planning to become pregnant;
- •b. Lactating or nursing subjects;
- •c. Using hormonal contraceptive (either oral/implants);
- •21. Participated in any clinical investigation requiring repeated blood sampling, blood donation, or have blood loss of >500 mL in past 8 weeks or participated in any clinical study within the past 3 months prior to first dosing of the study;
- •22. Any major illness or hospitalization within 90 days prior to first dosing of the study;
- •23. History of difficulty in accessibility of veins in arms.
研究者
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