An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study comparing Quetiapine film coated tablets 300 mg (Manufactured by Dr. Reddys Laboratories Ltd., India) to the reference listed drug Seroquel® film coated tablets 300 mg (Manufactured by AstraZeneca Pharmaceuticals LP, USA) under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Quetiapine 600 mg per day.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated tablets 300 mg) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions
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 film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated 300 mg tablets) in Schizophrenic patients under fasting conditions stabilized on Quetiapine 600 mg per day. 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. In accordance with the FDA guidance for the demonstration of bioequivalence for Quetiapine fumarate (Finalised May 2008)4, bioequivalence of a generic version of Quetiapine tablets to the reference listed drug (RLD) Seroquel should be established using 3 in vivo studies: two single dose studies in healthy subjects with Quetiapine 25 mg administered under both fasting and fed conditions, and a steady-state study with Quetiapine 300 mg administered in schizophrenic patients already receiving Quetiapine in a stable regimen. The design proposed in this protocol complies with FDA recommendation for the latter study.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 periodThis study will enroll 54 adult Schizophrenic patients. The anticipated date of enrollment would be on 07 April 2010.Total Blood Loss:Not exceeding 197 + 10 mL for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Written informed consent for participation in the study by the patient and Patient?s Legally Acceptable Representative (LAR).
- •If the patient or his/her legally acceptable representative is unable to read/write ?
- •an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
- •2.Patient has a documented clinical diagnosis of stable schizophrenia (DSM IV-TR) controlled by a stable 300 mg Quetiapine regimen given at 12-hour intervals from at least 2 weeks prior to the first dosing, as confirmed by Principal Investigator
- •Having a Body Mass Index (BMI) between 18 and 35 (inclusive), calculated as weight in kg / height in m
- •Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG recordings and Chest X ray (Postero-anterior view).
- •5.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
- •6.Able to comply with study procedures in the opinion of the investigator.
排除标准
- •1.Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.2.Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.3.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.4.History of syncope or orthostatic hypotension.5.Ingestion of any medication other than listed below at any time in 10 days before the first study drug administration.
- •In any such case Patient selection will be at the discretion of the Principal Investigator.
- •Following is the list of permissible medications, provided, the patients are on a stable regimen at least 10 days prior to and throughout the study.
- •Alprazolam, Fluoxetin, Imipramine, Haloperidol, Resperidone.
- •(Refer Appendix-I for list of nonpermissible medication)6.A history of alcohol or drug dependence by DSM-IV criteria within 6 months prior to screening.7.Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.8.Donation of blood (≥ 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
结局指标
主要结局
To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated tablets 300 mg) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions
时间窗: NIL
次要结局
- To monitor the safety of the patients who are exposed to the investigational medicinal product.(NIL)