NCT00347815Unknown1 期
Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers
Danish University of Pharmaceutical Sciences2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •healthy 18-40 years able to follow the protocol able to provide informed consent
排除标准
- •Allergy to buprenorphine
- •Mental illness
- •Alcohol or drug abuse
- •Chronic pain
- •Daily use of analgesics
- •Chronic medicinal treatment
- •Treatment with corticosteroids
- •Any use of medicine 48 hours before day of trial
- •Blood donation within 3 months before day of trial
- •Abnormal ECG
- •Abnormal blood values:
- •Serum creatinine > 100 umol/l Serum haemoglobin < 8 mmol/L LDH < 105 U/L or > 255 U/L ASAT > 45 U/L ALAT > 70 U/L PP < 0.9 INR or > 1.1 INR Alkaline phosphatase < 35 U/L or > 275 U/L K+ < 3,5 mmol/L or > 5,0 mmol/L Na + < 136 mmol/L or > 146 mmol/
研究者
研究点 (2)
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