ACTRN12613000892718已完成1 期
A Randomised, Placebo-Controlled, Double-Blind, Single Dose Escalation Study to evaluate the Safety, Tolerability and Pharmacokinetics of Betahistine Dihydrochloride Following a Single Intranasal Dose in Healthy Male and Female Volunteers.
Otifex Therapeutics Pty Ltd0 个研究点目标入组 24 人开始时间: 2013年8月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy male and female volunteers having Body Mass Index (MBI) between 18 and 30kg/m2 inclusive.
- •Normal (Type A) tympanometric measurements at screening consistent with the normal healthy adult population.
排除标准
- •History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease; any acute infectious disease or signs of acute illness, especially of the ear, nose or throat (ENT).
- •History of recurrent ENT infections, irritation or localized reaction to intranasally applied agents.
- •Recent ENT surgery (within 3 months of screening).
研究者
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