CTRI/2011/08/001949已完成不适用
A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO-TREATMENT, TWOSEQUENCE, CROSS-OVER, STEADY-STATE BIOEQUIVALENCE STUDY OF QUETIAPINE FUMARATE TABLETS 300 MG MANUFACTURED BY AMNEAL (TEST) WITH SEROQUEL® (QUETIAPINE FUMARATE) 300 MG TABLETS MANUFACTURED BY ASTRAZENECA (REFERENCE) IN ADULT SCHIZOPHRENIC PATIENTS ALREADY RECEIVING/ STABILIZED WITH QUETIAPINE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- 1. AUC0-tau: Area under the plasma concentration to time curve over the steady state
研究概览
简要总结
This is a Multicentrer, Open Label, Randomized, Two-Treatment, Two-Sequence, Crossover, Steady state Bioequivalence Study of Two formulations of Quetiapine fumarate tablet 300 mg in Adult Patients suffering from schizophrenia. It is expected that sponsors test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. Anticipated date for first patient enrolment in the study is end of August, 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult schizophrenic patients with body mass index (BMI) between 18 and 35kg/m2, inclusive, and aged between 18 and 60 years, inclusive.
- •on stable regimen with Quetiapine 300 mg IR preparation Q12h
- •Confirmed by a psychiatrist according to the Diagnostic and Statistical Manual IV (DSM IV) criteria
- •Able to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the investigator and to comply with the requirements of the entire study
- •Signed written informed consent prior to inclusion in the study witnessed by a legally acceptable representative or guardian
- •Should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray
- •Body weight ≥ 45kgs
- •Adequate hemoglobin i.e. ≥10gm/dL
- •Adequate renal function at screening as defined by Creatinine 1.5 X ULN for the clinical laboratory
- •Female patients of childbearing potential must be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, etc.
- •during the study.
排除标准
- •Known to have significant orthostatic hypotension
- •Known to have tachycardia or tachyarrhythmia
- •Bouts of uncontrolled seizures
- •Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson¡¯s disease or Alzheimer¡¯s dementia
- •Used any investigational drug within 3 months before Screening
- •On anticoagulants
- •Blood donations/ losses within 60 days of Screening
- •history of arrhythmias, hypokalemia, hypomagnesemia, or congenital QT prolongation History of multiple syncopal episodes
- •History of alcoholism within 3 months prior to Screening
- •History of drug abuse or dependence within 3 months prior to Screening
- •A value at Screening is greater than 1.5 times the upper limit of reference range for AST, ALT, direct bilirubin, total triglycerides, or total cholesterol
- •Contraindications or hypersensitivity to the use of Quetiapine or related group of drugs
- •Class III heart failure with evidence of recent progression, or Class IV heart failure per NYHA functional classification system
- •Uncontrolled and untreated hypertension
- •Myocardial infarction or acute coronary syndrome within 6 months prior to Screening
- •Significant pre-existing gastrointestinal co-morbidities that would preclude compliance with oral medication.
- •History of suicidal tendencies within the past 3 months prior to Screening or immediate risk of harm to self or other at the time of Screening, as judged by the investigator
- •Uncontrolled and un-treated diabetes mellitus
- •An unusual or abnormal diet, for whatever reason e.g. religious fasting
- •Smoking¡Ý 9 cigarettes/beedies per day
- •With bleeding disorders
- •On treatment with alpha adrenergic receptor blocking agents
- •Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study medication (Day 1)
- •Lactating female
- •On class 1A antiarrhythmics, class III antiarrhythmics, antipsychotics, antibiotics, other drugs associated with QT prolongation
- •On drugs which are enzyme inducer or inhibitors of CYP450 3A4, 5, and 7.
结局指标
主要结局
1. AUC0-tau: Area under the plasma concentration to time curve over the steady state
时间窗: Dosing interval on day 5 and day 10.
dosing interval.
时间窗: Dosing interval on day 5 and day 10.
3. Cmin-ss: Minimum concentration over the steady state dosing interval.
时间窗: Dosing interval on day 5 and day 10.
2. Cmax-ss: Maximum concentration over the steady state dosing interval.
时间窗: Dosing interval on day 5 and day 10.
次要结局
- 1. Css-avg: Average concentration over the steady state dosing interval.(2. Percentage fluctuation: [Cmax-ss – Cmin-ss / Css-avg] x 100)
研究者
研究点 (3)
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