NCT00446771已完成1 期
A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
Syntara0 个研究点目标入组 18 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- To determine the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously.
研究概览
简要总结
The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has signed a written informed consent form.
- •Subject is a normal male volunteer between 18 and 65 years of age.
- •Subject is willing to comply with the procedures of the study and to remain in the clinical unit for the scheduled visits.
- •Subject is willing to abstain from chewing gum for the duration of the study.
排除标准
- •Subject has asthma or other disease affecting the lungs or airways.
- •Subject has a history indicating possible airway hyperresponsiveness.
- •Subject is allergic to mannitol or gelatin or a known intolerance to intravenous mannitol.
- •Subject uses inhaled drugs (legal or illegal).
- •Subject uses oral bronchodilator drugs.
- •Subject has celiac disease, Crohn's disease or other disease affecting intestinal absorption.
- •Subject has renal impairment or other condition that would affect urine collection.
- •Subject's weight deviates by more than 15% from the ideal weight listed for his height in the Metropolitan Life table.
- •Subject is a smoker.
- •Subject has participated in another clinical trial within the past 30 days.
- •Subject has used chewing gum within the past 72 hours.
- •Subject needs to use bisphosphonates, non-steroidal anti-inflammatory agents, or other drugs known to affect intestinal permeability on a chronic basis.
- •Subject has used non-steroidal anti-inflammatory agents within the past 72 hours
结局指标
主要结局
To determine the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously.
To determine the relative bioavailability of mannitol powder for inhalation by comparison to orally administered mannitol.
To determine the pharmacokinetic parameters of systemically available mannitol after administration of mannitol powder by inhalation.
次要结局
- A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.
研究者
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