Pharmacokinetics of salmeterol regarding uptake and excretion MedDRA version: 17.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Serevent
Product Name: Serevent
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: SALMETEROL
CAS Number: 89365-50-4
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Bispebjerg University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Denmark
Contacts
Public ContactMorten Hostrup Nielsen
Bispebjerg University Hospital
Outcome results
None listed