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临床试验/NCT00519259
NCT00519259Unknown1 期

Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
1 期
入组人数
12
试验地点
2
主要终点
Tolerability

研究概览

简要总结

The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must be able to provide written informed consent
  • Must have a body mass index between 18 and 30
  • Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
  • Must have a negative drug test at screening and admission
  • If female of child bearing potential, must agree to use birth control

排除标准

  • Please contact the site for more information

结局指标

主要结局

Tolerability

次要结局

  • Safety
  • Pharmacokinetic parameters
  • Cardiovascular responses
  • Psychological effects of lobeline

研究者

申办方类型
Nih

研究点 (2)

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