NCT00923000Unknown1 期
Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The pharmacokinetic parameters
研究概览
简要总结
The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.
详细描述
This study is a single center and open-label design to investigate the pharmacokinetic properties of Nubian, Nubian traditional Chinese herb combination dosage after single oral with oral administration, or morphine, morphine traditional Chinese herb combination dosage after single oral administration in healthy volunteers under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal healthy adult subjects between 20-40 years of age
- •Body weight within 80-120% of ideal body weight
- •Acceptable medical history, physical examination and clinical laboratory determinations
排除标准
- •Recent history of drug or alcohol addiction or abuse
- •Donating greater than 150 ml of blood within two months prior to Period I
- •Taking any prescription medication or any nonprescription medication within 14 days prior to Period I doing
- •Receiving any investigational drug within 30 days prior to Period I dosing
- •Taking any drug known to induce or inhibit hepatic drug metabolism within 30 days prior to the beginning of the study
- •Any clinically significant diseases
- •History of allergic response to nalbuphine or related drugs and traditional Chinese herbs
研究组 & 干预措施
Nubian with Long dan xie gan tang 3g
Experimental
干预措施: Nubian with Long dan xie gan tang (Drug)
Nalbuphine
Active Comparator
干预措施: Nalbuphine (Drug)
Morphine
Active Comparator
干预措施: Morphine (Drug)
Morphine with Long dan xie gan tang
Experimental
干预措施: Morphine with Long dan xie gan tang (Drug)
Nubian with Long dan xie gan tang 3g tid
Experimental
干预措施: Nalbuphine with Long dan xie gan tang (Drug)
结局指标
主要结局
The pharmacokinetic parameters
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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