NCT02599740已完成不适用
The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels
Unilever R&D1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
研究概览
简要总结
This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
详细描述
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m
- •Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] and inflammatory diseases).
- •Fasting blood glucose value of subjects is ≥ 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening.
排除标准
- •Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.
结局指标
主要结局
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
时间窗: 0-2 hours
+iAUC
次要结局
- Change of 3-h PPG based on response to different treatments(0-3 hours)
- Change of 2-h and 3-h post-prandial insulin based on response to different treatments(0-2 hours and 0-3 hours)
- Half-life of elimination phase for assumed key active(0-12 hours)
- Total amount of assumed key active excreted in urine(0-36 hours)
- Time of max plasma concentration for assumed key active(0-12 hours)
- Max plasma concentration for assumed key active(0-12 hours)
- AUC for plasma concentration versus time curve for assumed key active(0-12 hours)
研究者
研究点 (1)
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