CTRI/2019/08/020536已完成不适用
An Open label, Multi-centre, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Multiple-dose, Steady-state, Cross-over, Bioequivalence study of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine Fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- To assess the bioequivalence of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA, when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.
研究概览
简要总结
The purpose of the study is to evaluate the bioequivalence of Quetiapine Fumarate tablets 300 mg, Prinston Pharmaceutical Inc with SEROQUEL® in adult schizophrenia patients.
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
- •1Male or female aged 18-65 years (both inclusive) with BMI 18 to 35 kg/m2 2Patients with clinically diagnosis of Schizophrenia (DSM-IV-TR) and who are in a stable regimen of Quetiapine 300 mg twice daily atleast one month prior to screening 3Not having any significant diseases or abnormal findings except schizophrenia.
- •4Acceptable Haematological parameters, Hepatic and Renal function at screening 5Patient should have adequate ability to provide decision for informed consent along with legally acceptable representative.
- •6Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal women for at least 12 consecutive months, must agree to use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile sexual partner for at least 2 weeks prior to the study and up to 30 days after the last dose of the study drug 7In case of male patients: Either partner or patient must use an effective method of contraception for avoiding pregnancy for at least 2 weeks prior to the study drug administration, during the study and up to 30 days after the last dose.
排除标准
- •i.History of Hypersensitivity to Quetiapine or any of the excipients of study drug.
- •ii.Patient with dementia related psychosis.
- •iii.Patient with a history of Neuroleptic malignant Syndrome (NMS).
- •iv.Any psychiatric illness (Other than Schizophrenia) neurological disorders, including neurologic malignant syndrome, major depressive disorder, organic mental disorder, severe tardive dyskinesia, Parkinson’s disease, history or presence of epilepsy or risk for seizures, history of multiple syncopal episodes or stroke.
- •v.Patient who had undergone exacerbation of Schizophrenia and ECT (Electro convulsive therapy) within two months from the screening.
- •vi.History of suicidal tendencies or or immediate risk of harm to self or other (e.g. suicidal attempts) within the past 2 months prior to screening as judged by the investigator.
- •vii.Patient with history or presence of seizures or other conditions that potentially lower the seizure threshold, cognitive and motor impairment.
- •viii.Hospitalization for an exacerbation of schizophrenia with in two Months.
- •ix.Patient with significant clinical relevant endocrinal, cerebrovascular, pulmonary, haematological, immunological and cardiovascular disease (e.g., heart failure, history of myocardial infarction or ischemia, conduction abnormalities, cardiomyopathy, myocarditis), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications).
- •Could lead to safety risk.
- •x.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval (QTc> 440 ms).
- •xi.Presence of uncontrolled metabolic disorders including uncontrolled diabetes mellitus (Fasting blood glucose levels greater than 160 mg/dl and HbA1c greater than or equal 8%), Serum total cholesterol greater than or equal 300 mg/dl and fasting serum triglyceride levels greater than or equal 300 mg/dl.
- •xii.Patient with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
- •xiii.Patient with known hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose¬galactose malabsorption.
- •xiv.Patient having Systolic Blood Pressure ≥ 140 mm Hg or Diastolic Blood Pressure ≥ 90 mm Hg. xv.Use of any of the following medications within 14 days prior to enrolment but not limited to: • Strong inhibitors of CYP3A4 • Strong inducers of CYP3A4 • Drugs associated with QT prolongation • Antihypertensive and other drugs known to cause hypotension xvi.Female patient with Positive Pregnancy test.
- •xvii.Patient with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
- •xviii.Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
- •xx.Medical or surgical condition that might interfere with the absorption, metabolism or excretion of Quetiapine.
- •xxi.Patient with chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
- •xxii.Patient with difficulty of donating blood or difficulty in accessibility of veins.
- •xxiii.Participation in a drug research study within past 3 months.
- •xxiv.A depot neuroleptic drugs within 3 months prior to administration of study medication.
- •xxv.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 e.g. 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 assess the bioequivalence of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA, when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.
时间窗: During the entire duration of the trial
次要结局
- To assess the bioequivalence of Quetiapine Fumarate tablets 300 mg of Prinston Pharmaceutical Inc. comparing with that of SEROQUEL® (Quetiapine fumarate) tablets 300 mg of AstraZeneca Pharmaceuticals LP, USA, when administered twice daily in adult schizophrenia patients already receiving Quetiapine in a stable regimen.(During the entire duration of the trial)
研究者
研究点 (5)
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