CTRI/2017/08/009291已完成不适用
A randomized, open-label, two-treatment, two-period, cross-over, multiple dose, steady state, multi-centre comparative bioequivalence study of Quetiapine Extended-Release Tablets, USP 400 mg manufactured by Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Rajoda, Ahmedabad, India for Amneal Pharmaceuticals, with SEROQUEL XR® (quetiapine fumarate extended release tablets) 400 mg manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in patients suffering from schizophrenia under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- To characterize pharmacokinetic profile of test product (T) and reference Product (R) and assess their bioequivalence.
研究概览
简要总结
The present study aims to evaluate bioequivalence of Sponsor’s test formulation against corresponding reference product SEROQUEL XR® (quetiapine fumarate extended release tablets) 400 mg manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate extended release tablets EQ 400 mg base once daily.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Either sex, aged 18 to 65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR)
- •Receiving a stable dose of Quetiapine Fumarate extended release tablets treatment for at least 1 month prior to randomization and is on Quetiapine Fumarate extended release tablets EQ 400 mg base once daily dosage at the time of screening.
- •Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
- •Females of childbearing potential (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) must have a negative pregnancy test (at screening, before randomization and before check-in to housing i.e., day 0) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.
排除标准
- •History of allergic reactions to Quetiapine or other component of the extended release formulation.
- •Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, alcoholic and other toxic psychoses, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
- •History of suicidal tendencies (i.e., suicidal attempts) 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.
- •History of Neuroleptic Malignant Syndrome, cardiovascular disease [ischemic heart disease (including myocardial infarction), heart failure (including congestive heart failure or significant heart hypertrophy) or conduction abnormalities (including bradyarrythmia, congenital QT prolongation or family history of QT prolongation)], cerebrovascular disease, drug induced leucopenia/ neutropenia, seizures or with conditions that potentially lower the seizure threshold e.g. Alzheimer’s dementia
- •History of multiple syncopal episodes or presence of significant orthostatic hypotension at screening or before check-in to housing on day 0; Orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
- •Current/ recent (within 3 months) history of uncontrolled epilepsy or risk for seizures
- •A medical or surgical condition that might interfere with theabsorption, metabolism or excretion of Quetiapine
- •Drug abuse or alcohol dependence in last 1 year period before enrolment (except dependence in full remission), as defined by DSM IV-TR criteria and as positive result in breath alcohol testing/ urine screen for drug of abuse (except for prescribed benzodiazepines).
- •Any of the following investigational abnormality in screening: WBC count < 3000/mm3 (3.0x109 Absolute Neutrophil Count <1500/mm/l),3 (1.5x109) Serum creatinine> 1.5 mg/dL /l), QTc> 500 milliseconds (in ECG of screening or day 0) SGOT/ SGPT >3 times Upper Limit of Normal range (ULN) HbA1c> 9% Reactive to anti-HIV, HBsAg, anti-HCV 10.Use of any of the following in the 14 days preceding enrolment including but not limited to: Strong inhibitors of CYP3A
- •Strong inducers of CYP3A
- •Drugs associated with QT prolongation.
- •Participation in another clinical trial or use of other investigational product/ device within 4 weeks prior enrollment into this study.
- •Blood donation/blood loss exceeding 200 ml within 90 days prior to enrollment in the study.
- •13.Any condition/Abnormal baseline findings that in the investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study i.e., low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
结局指标
主要结局
To characterize pharmacokinetic profile of test product (T) and reference Product (R) and assess their bioequivalence.
时间窗: 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 18.00 and 24.00 hrs
次要结局
- To monitor the safety and tolerability of a multiple doses of Quetiapine Fumarate extended release tablets EQ 400 mg base in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate extended release tablets EQ 400 mg base once daily.(Monitoring and Reporting of Adverse Events.)
研究者
研究点 (4)
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