NCT03317236已完成4 期
Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
- •Gender: males and non pregnant females
- •Age: 18 to 55 years.
- •Body mass index: 19 to 27 kg/m^2.
排除标准
- •History of liver or renal disease, or psychiatric disorders.
- •History of drug or alcohol abuse during the previous two years.
- •Smokers of more than 10 cigarrettes a day.
- •Any kind of medicines taken during the previous two weeks.
- •Any history of disease or disorders clinically significant according to the Principal Investigator.
- •Abnormal ECG.
- •Abnormal chest X-ray.
- •Hypersensitivity to quetiapine or excipients within the formulations.
- •Positive diagnostic test for HIV or hepatitis A, B or C virus.
- •Breast feeding females.
- •Positive beta-HCG test.
- •Positive drug test in urine.
- •Participation in clinical trials in the previous three months.
- •Blood donation in the previous three months.
- •Clinically significant laboratory results.
- •Subjects seeking to initiate any medical or pharmacological treatment.
- •Subjects unwilling to keep fasting or diet indications.
- •Uncooperative subjects.
研究组 & 干预措施
Reference - Test
Experimental
A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).
干预措施: Quetiapine (Drug)
Test - Reference
Experimental
A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).
干预措施: Quetiapine (Drug)
结局指标
主要结局
Cmax
时间窗: 36 hours
Maximum plasma concentration
AUC
时间窗: 36 hours
Area under curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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