NCT02196805已完成不适用
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- BE parameters: AUC0-t
研究概览
简要总结
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
- •Non-smokers
- •Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
- •Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
- •Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
- •Willing to adhere to the study procedures described in this protocol
排除标准
- •History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
- •Known hypersensitivity history to any prescription drug or over-the-counter medication
- •Use of the following medications or products during the periods specified below:
- •Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration
- •Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of the study
- •Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the start of the study
- •Body weight <50kg
- •History of drug abuse within past 5 years or positive urine drug screen results
- •Subjects who test positive in HIV,HCV antibody,HBS antigen
- •Otherwise judged by the investigator to be inappropriate for inclusion in the study
研究组 & 干预措施
1
Experimental
干预措施: Group A: imported Probucol ( Lorelco) (Drug)
2
Experimental
干预措施: Group B: Marketed Probucol ( Chang Tai) (Drug)
结局指标
主要结局
BE parameters: AUC0-t
时间窗: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
BE parameters: Cmax
时间窗: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
次要结局
- Pharmacokinetic Parameters: t1/2(blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration)
- Pharmacokinetic Parameters: Cmax(blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.)
- Pharmacokinetic Parameters: Tmax(blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration)
- Pharmacokinetic Parameters: AUC0-t(blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration)
- Pharmacokinetic Parameters: AUC0-∞(blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration)
研究者
研究点 (1)
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