CTRI/2012/05/002632已完成不适用
An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentricexperimental bioequivalence study comparing Quetiapine film coated tablets 300 mg (Manufactured by HeteroLabs Limited, India) to the reference listed drug Seroquel® film coated tablets 300mg (Manufactured by AstraZeneca USA) under fasting conditions after multiple dose administration at steady state in adultschizophrenic patients stabilized on Quetiapine 600 mg per day.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- tablets) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions and to
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 and to assess the bioequivalence. 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.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) and on a stable dose of Quetiapine 600 mg per day for at least 10 days prior to screening.
- •Having a Body Mass Index (BMI) between 18 and 30 (both inclusive), calculated as weight in kg / height in m
- •The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
- •Able to comply with study procedures in the opinion of the investigator.
- •Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must 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 [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Quetiapine and its excipients.
- •Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia.
- •Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg within three minutes of standing up).
- •History of syncope or orthostatic hypotension.
- •A recent history of alcoholism (less than 2 years) or daily consumption of moderate (180 mL/day) alcohol use, or consumption of alcohol or alcoholic products within 48 hour prior to receiving study medication or inability to abstain from alcohol during the study.
- •Smokers who has inability to abstain from smoking during the study.
- •Known case of HIV infection.
- •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.
- •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.
- •History of agranulocytosis.
- •Pregnant or lactating females.
结局指标
主要结局
tablets) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions and to
时间窗: -
assess the bioequivalence.
时间窗: -
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
时间窗: -
次要结局
- To monitor the safety of the patients who are exposed to the investigational medicinal product.(_)
研究者
研究点 (4)
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