Study to Detect Oral Administration of Budesonide in Women. (WADA)
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|ClinicalTrials.gov Identifier: NCT03537326|
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Budesonide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Healthy women, aged between 18 and 45 years old, weighing between 50 and 75 kg and with BMI included between 19 and 27 kg/m².|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Study to Detect Oral Administration of Budesonide in Women.|
|Actual Study Start Date :||May 22, 2018|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||September 10, 2018|
Healthy women, aged between 18 and 45 years old, with weigh between 50 and 75 kg and with IMC included between 19 and 27 kg/m². Patients will be given, on an empty stomach since 10 hours minimum, a single dose of 3 mg of Budesonide, in the form of Entocord ® tablets. 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.
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.
Other Name: Entocord® modified release capsule, 3 mg single-dose
- 6β-hydroxy-budesonide urine concentration. [ Time Frame: 0-4 hr (hours) ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 h ; 72-96 hr after administration ]Many defined times after the oral administration of Entocord®, urine sample will be collected by the subjects and then analysed in laboratory to determine 6β-hydroxy-budesonide concentration.
- Medication and other metabolites urine concentrations. [ Time Frame: 0-4 hr ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 hr ; 72-96 hr after administration ]Many defined times after the oral administration of Entocord®, urine samples will be collected by the subjects and then analysed in laboratory to determine concentrations of Entocord® and other metabolites of budesonide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537326
|Barcelona, Spain, 08003|
|Principal Investigator:||Rosa Ventura Alemany, Pharmacéutic||Laboratorio Antidopaje de Catalunya.|