EUCTR2018-002529-48-DK进行中(未招募)1 期
rine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis
Center for Aktiv Sundhed, Rigshospitalet0 个研究点目标入组 26 人开始时间: 2018年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Included subjects are:
- •- 18 - 39 years
- •- Able to use an inhalation device
- •- Active at least 5 hours a week
- •- VO2-max classified as high or very high measured during incremental test to exhaustion during the screening visit
- •- Male or non-pregnant female
- •- Females of childbearing potential has to use one or more methods for contraception in order to be included: vasectomised partner, bilateral tubal occlusion, sexual abstinence, intrauterine device or hormonal contraception.
- •- Females who are considered to have no childbearing potential are: bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy, postmenopausal defined as 12 months with no menses without an alternative Medical cause.
- •- Non-smokers
- •- No daily use of prescribed medicine
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diagnosis of Heart, pulmonary (including asthma GINA 2-5), intestinal and renal diseases
- •- Allergy towards active drug or any substances used in the drug
- •- Non-compliance with the protocol
研究者
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未知
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