Pharmacological effects of acute and accumulated salbutamol in relation to doping analysis
Phase 1
- Conditions
- Pharmacological effects of acute and accumulated salbutamol in relation to doping analysisTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2016-002819-18-DK
- Lead Sponsor
- Bispebjerg University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
•Male and female aged 18-45 years
•Physical active, at least 2 times a week
•VO2-max at least 45 ml/min/kg (women) and 50 ml/min/kg (men)
•Non-smokers
•No daily use of 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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Hypersensitivity towrads the active substance or any one of the other substances within the medicine.
Coronary heart desiease, asthma or other cronical disease
Not able to get doctors permission to participate in the trial after an objective examination
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim is to investigate the pharmaco dynamics and kinetics for acute and accumulated salbutamol in relation to doping analysis;Secondary Objective: Not applicable;<br> Primary end point(s): Urine concentrations of salbutamol<br> Performance test (wingate)<br> ;Timepoint(s) of evaluation of this end point: Spring 2019
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable