A randomized, open-label, two-treatment, two-period, cross-over, multiple dose, steady state, multi-centre comparative bioequivalence study of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base manufactured by Amneal Life Sciences Pvt. Ltd. India with SEROQUEL XL (Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- To assess bioequivalence of the test product (T) – Quetiapine Fumarate prolonged-release tablets EQ 400 mg basemanufactured by Amneal Life Sciences Pvt. Ltd., India compared to that of the reference product (R)– SEROQUEL XL(Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily
研究概览
简要总结
This is A randomized, open-label, two-treatment, two-period, cross-over, multiple dose, steady state, multi-centre comparative bioequivalence study of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base manufactured by Amneal Life Sciences Pvt. Ltd. India with SEROQUEL XL (Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia under fasting conditions.A randomized, open-label, two-treatment, two-period, cross-over, multiple dose, steady state, multi-centre comparative bioequivalence study of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base manufactured by Amneal Life Sciences Pvt. Ltd. India with SEROQUEL XL (Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia under fasting conditions.Primary objective: To characterize pharmacokinetic profile of the test product (T) – Quetiapine Fumarate prolonged-release tablets EQ 400 mg basemanufactured by Amneal Life Sciences Pvt. Ltd., India compared to that of the reference product (R)– SEROQUEL XL(Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily and to assess their bioequivalence. Secondary Objective: To monitor the safety and tolerability of a multiple doses of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily.Patients will be housed for entire study period from study days 0 to 11 and will be administered IP under supervision of investigator/ designee on all 10 study days e.g. period I – days 1 to 5 & period II – days 6 to 10. In morning of each study day, after overnight fast of at least 10 hours, patient will be administered oral dose of single tablet of IP (Quetiapine Fumarate prolonged-release tablets EQ 400 mg base as per site specific randomization schedule) with approximately 240 mL of water at ambient temperature in sitting position, under supervision of investigator/ designee. On study days 5 & 10, post dose sampling will be done at 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, 14.00and 18.00 hours after IP dose. On study days 6 & 11, last post dose sample will be collected at 24.00 hours after IP dose on days 5 & 10, respectively. Total number of pharmacokinetic blood samples: 44 (22/ period). Total blood loss in study: approximately 321 ml for patient (including 3 safety samples: approx 15 ml at screening and approx 10 ml at end of each period). On study days 5 & 10, post dose sampling will be done at 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, 14.00and 18.00 hours after IP dose. On study days 6 & 11, last post dose sample will be collected at 24.00 hours after IP dose on days 5 & 10, respectively. Total number of pharmacokinetic blood samples: 44 (22/ period). Total blood loss in study: approximately 321 ml for patient (including 3 safety samples: approx 15 ml at screening and approx 10 ml at end of each period)
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 Quetiapine Fumarate prolonged-release tablets treatment for at least 1 month prior to randomization and is on Quetiapine Fumarate prolonged-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 e.g. 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 prolonged-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 (e.g. 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 the absorption, 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: ï‚· WBC count 3000/mm3 (3.0x109/l), ï‚· Absolute Neutrophil Count 1500/mm3 (1.5x109/l), ï‚· Serum creatinine 1.5 mg/dL ï‚· QTc 500 milliseconds (in ECG of screening or day 0) ï‚· SGOT/ SGPT 3 times Upper Limit of Normal range (ULN) ï‚· HbA1c 9% ï‚· Reactive to antiHIV, HBsAg, antiHCV
- •Use of any contraindicated medications in the 14 days preceding enrolment Use of any of the following in the 14 days preceding enrolment.
结局指标
主要结局
To assess bioequivalence of the test product (T) – Quetiapine Fumarate prolonged-release tablets EQ 400 mg basemanufactured by Amneal Life Sciences Pvt. Ltd., India compared to that of the reference product (R)– SEROQUEL XL(Quetiapine Fumarate) 400 mg prolonged-release tablets marketed by AstraZeneca UK Ltd. in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily
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 adverse events, safety and tolerability of a multiple doses of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base in patients suffering from schizophrenia who are already on a stable regimen with Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily.(Not Applicable)