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临床试验/EUCTR2018-002529-48-DK
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

发起方
Center for Aktiv Sundhed, Rigshospitalet

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