The Safety Evaluation of Theophylline and Bambuterol When Administered Orally Alone and in Combination to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with the primary objective of testing the safety and tolerability of combined oral doses of theophylline and bambuterol in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in combination. It is hypothesized that the combination of these drugs is generally safe, and that no drug interaction can be observed.
详细描述
This is a Phase I, three period, two sequence, single-center, open-label, randomized, crossover study design. Periods I and II consist of the oral administration of either a single dose of theophylline or bambuterol alone, followed by a 7 day wash out interval. Subsequently, Period III consists of the simultaneous administration of both drugs. All subjects are to be confined to the Oslo University Hospital Research Unit throughout all treatment periods [Study Day 1, 7 and 14]. A sufficient number of healthy adult subjects will be consented in order to enroll 20 and complete 16 subjects who complete all three periods. Replacement of subjects is permitted, if necessary.
Qualified subjects will be randomized into one of two sequences consisting of three Periods as indicated below:
-------------Period 1-----Period 2-----Period 3
Sequence A: Treatment 1 Treatment 2 Treatment 3
Sequence B: Treatment 2 Treatment 1 Treatment 3
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Theophylline
干预措施: Theophylline and Bambuterol (Drug)
Bambuterol
干预措施: Theophylline and Bambuterol (Drug)
结局指标
主要结局
Adverse Events
时间窗: 24 hours after dosing
To assess the Number of Participants with Adverse Events after dosing, as a Measure of Safety and Tolerability
Pharmacokinetic
时间窗: 24 hours after dosing
To assess the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in combination. PK sample collections for plasma Theophylline and Bambuterol determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post dose
次要结局
未报告次要终点
研究者
Trond-Eirik Strand
Assistant Director General
Norwegian Armed Forces Medical Service