NCT03537326

Study to Detect Oral Administration of Budesonide in Women.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims at identifying analysis strategies to detect oral administration of Budesonide in women; in order for them to be used by the accredited laboratories of the Worl Anti-Doping Agency (WADA).

Detailed description

This clinical trial aims at studying the budesonide metabolism of women. The objective is to identify analysis strategies to detect oral administration of Budesonide in women. In order to use them in the accredited laboratories of the Worl Anti-Doping Agency (WADA). This study will also help with defining the referential levels of this way of administration. Also, it will be used to test the safety and tolerability of the medication used. For this, will be collected at precise times after the oral administration of the medication, the concentrations in urines of the metabolite o budesonide : the 6bêta-hydroxy-budesonide, of budesonide itself, of other metabolites. These concentrations will be compare to the ones in the basal samples of subject's urines.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Budesonide	Patients will be given, on an empty stomach since a minimum of 10 hours, a single dose of 3 mg of Budesonide, in the form of Entocord® capsuls. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.

Timeline

• Start date: 2018-05-22
• Primary completion: 2018-07-01
• Completion: 2018-09-10
• First posted: 2018-05-25
• Last updated: 2018-09-11

Locations

1 site across 1 country: Spain