跳至主要内容
临床试验/NCT00600678
NCT00600678已完成不适用

Characterisation of Gastric Emptying of a High Caloric Sip Feed Using the Paracetamol Absorption Method: Intraindividual Comparison of Paracetamol Pharmacokinetics After Oral co-Administration With Sip-Feed and After Intravenous Administration in Healthy Volunteers of Both Genders in an Open, Single Centre Study

Fresenius Kabi2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
- Gastric emptying after a single oral administration of a nutritional supplement

研究概览

简要总结

Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • caucasian origin
  • BMI: 22kg/m2 - 27kg/m2;

排除标准

  • existing diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of paracetamol (e.g. gastrointestinal or liver disease),
  • known allergic reactions to investigational products,
  • diseases and/or pathological findings, which could affect absorption, metabolism and/or gastric emptying (e.g. dyspepsia and gastroesophageal reflux),
  • regular medication which can influence hepatic biotransformation and/or absorption,
  • alcohol dependence, blood donation;

结局指标

主要结局

- Gastric emptying after a single oral administration of a nutritional supplement

时间窗: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.

次要结局

  • safety and tolerability(entire study)

研究者

申办方类型
Industry

研究点 (2)

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