Pharmacological Properties of Salmeterol

Pharmacokinetics in Healthy Young Men Clinical Trial

Official title:

Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558088
• Other study ID #: WADA2013sal
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2015
• Last updated: January 29, 2017
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.

Hence, there is no hypothesis as such.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male

• 18-45 years

• Healthy

Exclusion Criteria:

• Chronic disease

• Smoking

• Habitual use of medicine

• Allergy towards salmeterol

• Unable to exercise on a bike ergometer

Related Conditions & MeSH terms

• Pharmacokinetics in Healthy Young Men

Intervention

Drug:
• Salmeterol

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Select State

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine concentration of salmeterol		0-24 hours after administration of the study drug