CTRI/2015/10/006303尚未招募未知
An open label, randomized, two treatments, two sequences, two periods, multiple dose, steadystate, crossover, oral bioequivalence study of DICOMEX (Clozapine) 100 mg tablet ofLaboratorios Recalcine S.A., Chile and Clozaril® (Clozapine) 100 mg tablet of NovartisPharmaceutical Corporation, East Hanover, New Jersey, USA in 36 schizophrenic subjects underfasting conditions
aboratorios Recalcine SA0 个研究点目标入组 36 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
- 36
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
- •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
- •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.
排除标准
- •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
- •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.
研究者
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