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 Intas Pharmaceuticals Ltd., 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 adult schizophrenic 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
- 48
- 试验地点
- 5
- 主要终点
- Primary PK Parameters: Cmax,ss and AUC,ss
研究概览
简要总结
The multidose pharmacokinetics of Quetiapine are dose proportional within the proposed clinical dose range and Quetiapine accumulation is predictable upon multi dosing. In the present study, the relative bioavailability of Quetiapine film coated tablets 300 mg from the test formulation in comparison to the reference product Seroquel® film coated 300 mg tablets will be assessed under fasting conditions at steady state after multiple dose administration in Schizophrenic patients stabilized on Quetiapine 600 mg per day Rationale:The Sponsor has developed the test formulation. This study is being conducted to compare the bioavailability and characterise the pharmacokinetic profile of the Sponsors 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. 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. 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. Objective:To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsors formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated 300 mg tablets) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditions and to assess the bioequivalence and safety of the patients
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
- •1.Written informed consent for participation in the study by the patient and Patient?s Legally Authorized Representative (LAR).
- •2.Schizophrenic patients, between 18 and 60years of age (inclusive).
- •3.Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 600 mg per day for at least 10 days prior to screening.
- •4.Having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m
- •5.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.
- •6.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
- •7.Able to comply with study procedures in the opinion of the investigator.
- •8.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 and day 5 (before dosing) must be negative.
排除标准
- •1.Known hypersensitivity or idiosyncratic reaction to Quetiapine and its excipients.
- •2.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.
- •3.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).
- •4.History of syncope or orthostatic hypotension.
- •5.Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.
- •6.The presence of clinically significant abnormal laboratory values during screening.
- •7.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
- •Note: In case the blood loss is less than or equal to 200 mL; Patient may be dosed 60 days after blood donation.
- •8.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV IgM antibodies.
- •9.Known case of HIV infection.
- •10.Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
- •11.Presence of cataract on Opthalmoscopic examination (slit lamp exam).
- •12.History of seizures.
- •13.History of agranulocytosis.
- •14.Patients having Hypertension or on any antihypertensive medication.
- •15.Patients with Diabetes mellitus or fasting blood glucose ≥ 126 mg/dl at screening visit.
- •16.Patients with abnormal thyroid function test at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- •17.Patient with hyperprolactinemia at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- •18.Dementia related psychosis.
- •19.Pregnant or lactating females.
结局指标
主要结局
Primary PK Parameters: Cmax,ss and AUC,ss
时间窗: NIL
次要结局
- Secondary PK Parameters: Cmin,ss, Tmax, PTF and Css,av(NIL)