CTRI/2016/07/007065尚未招募未知
A multicentric open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, steady state bioequivalence evaluation of clozapine tablet 100 mg twice daily (test drug) with Clozaril® 100 mg tablets twice daily (reference drug, Novartis pharmaceuticals corporation, USA) after multiple dose administration in adult schizophrenic patients under fasting conditions - NA
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 38
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 Patientâ??s Legally Acceptable Representative (LAR).
- •2. Patient has a documented clinical diagnosis of schizophrenia according to DSM IV-TR
- •3. Patients have a diagnosis of treatment-resistant schizophrenia
- •4. Male or female patients between 18 and 60 years of age
- •5. Having a Body Mass Index (BMI) between 18 and 30 (both inclusive), calculated as weight in kg / height in m2.
- •6. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening
- •7. Patients have been on a daily stable dose of 200 mg clozapine formulation
- •8. Able to comply with study procedures in the opinion of the investigator.
- •9. Both male and female patients of child bearing potential must be practicing adequate contraception.Female patients of child-bearing potential must not be orlikely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
排除标准
- •1. Patient with known hypersensitivity/ intolerance to clozapine or any other component of the drug.
- •2. Clinically symptomatic orthostatic hypotension
- •3. Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
- •4. Concurrent primary psychiatric or neurological diagnosis (except schizophrenia), including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
- •5. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic).
- •6. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine.
- •7. Known case of poor metabolizer individuals with reduced activity of cytochrome P450 enzymes particularly, 1A2, 2D6 and 3A4.
- •8. Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.
- •9. Positive tests for drug or alcohol abuse
- •10. A history of alcohol or drug dependence during the 6-month period immediately prior to study entry
- •11. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study medication or during the study.
- •12. 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.
- •13. A positive hepatitis screen including hepatitis B surface antigen, HCV.
- •14. Known case of HIV infection.
- •15. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •16. Presence of glaucoma
- •17. History of clozapine induced agranulocytosis or severe granulocytopenia
- •18. Patient with hyperprolactinemia
- •19. Concurrent use of other drugs known to suppress bone marrow function
研究者
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