An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental comparative evaluation of two formulations of Quetiapine extended release tablets 400 mg under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 400 mg per day.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Cmin,ss, Cmax,ss, AUCÏ„,ss
研究概览
简要总结
The Sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine Extended Release tablets 400 mg) with respect to the reference formulation (Seroquel XR 400 mg tablets) in Schizophrenic patients under fasting conditions stabilized on Quetiapine 400 mg per day and to assess the bioequivalence. As a high number of healthy subjects experienced serious adverse effects after administration of antipsychotics such as hypotension, tachycardia etc., regulatory authorities are recommending that studies should be conducted on Schizophrenic patients. Since the formulation being studied is a modified release formulation, a multiple dose, steady state study is being conducted as per the applicable regulatory guidance. The study is being conducted on schizophrenic patients who are on a stable dose of quetiapine, and the patients cannot be deprived of the quetiapine treatment during the washout period of the study. Hence, the study has been planned to be a continuous administration of the test and the reference formulation without any intervening washout period The total number of patients to be enrolled is around 100 from India and the expected date of first enrollment of the patient for the referenced study will be on 02 nd September 2009.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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
- •Schizophrenic patients, between 18 and 60 years of age (inclusive) and having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m
- •Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 400 mg per day for at least 10 days prior to screening
- •Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
- •The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to quetiapine.
- •Current or relevant history of serious, severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) except schizophrenia.
- •Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing up)
- •History of syncope or orthostatic hypotension
- •Any condition/ Abnormal baseline findings that in the investigator?s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
- •Patients with a known intolerance or lack of response to previous treatment with quetiapine.
- •Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •Patients having Hypertension or on any antihypertensive medication.
结局指标
主要结局
Cmin,ss, Cmax,ss, AUCÏ„,ss
时间窗: NIL
次要结局
- Ctrough, Tmax, t1/2, PTF, Css,av,λz(NIL)