ptake and excretion of salmeterol in healthy trained males

Phase 1

• Conditions: Pharmacokinetics of salmeterol regarding uptake and excretion; MedDRA version: 17.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2014-002139-33-DK
• Lead Sponsor: Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-02
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Male between 18-40
physically active at least 5 hours a week
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity towards the active substance or any of the other substances within the medicine
Coronary heart disease, asthma or other cronical disease
Not able to get doctors permission to participate in the trials after an objective test

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To help establish a urinary threshold for salmeterol on the prohibited list, as it has been done for Salbutamol and Formoterol. ;Secondary Objective: Not applicable;Primary end point(s): Urine concentration of salmeterol ;Timepoint(s) of evaluation of this end point: The end point will be evaluated in the spring of 2016

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable