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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004839-37 | EudraCT Number |
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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).
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 6bĆŖta-hydroxy-budesonide, of budesonide itself, of other metabolites. These concentrations will be compare to the ones in the basal samples of subject's urines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | 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 EntocordĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6β-hydroxy-budesonide urine concentration. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication and other metabolites urine concentrations. | Many defined times after the oral administration of EntocordĀ®, urine samples will be collected by the subjects and then analysed in laboratory to determine concentrations of EntocordĀ® and other metabolites of budesonide. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Ventura Alemany, PharmacƩutic | Laboratorio Antidopaje de Catalunya. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMIM | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8563509 | Background | Bai TR. Glucocorticosteroid treatment of asthma. Can Fam Physician. 1995 Nov;41:1921-7. | |
| 15634032 | Background | Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003. |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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| 12955741 | Background | Deventer K, Delbeke FT. Validation of a screening method for corticosteroids in doping analysis by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2003;17(18):2107-14. doi: 10.1002/rcm.1157. |
| 17689473 | Background | Duclos M. [Use and abuse of anabolic steroids and glucocorticoids in sport]. Ann Endocrinol (Paris). 2007 Sep;68(4):308-14. doi: 10.1016/j.ando.2007.06.022. Epub 2007 Aug 8. No abstract available. French. |
| 11554422 | Background | Fluri K, Rivier L, Dienes-Nagy A, You C, Maitre A, Schweizer C, Saugy M, Mangin P. Method for confirmation of synthetic corticosteroids in doping urine samples by liquid chromatography-electrospray ionisation mass spectrometry. J Chromatogr A. 2001 Aug 10;926(1):87-95. doi: 10.1016/s0021-9673(01)01065-2. |
| 16631183 | Background | Ho EN, Leung DK, Wan TS, Yu NH. Comprehensive screening of anabolic steroids, corticosteroids, and acidic drugs in horse urine by solid-phase extraction and liquid chromatography-mass spectrometry. J Chromatogr A. 2006 Jul 7;1120(1-2):38-53. doi: 10.1016/j.chroma.2006.03.089. Epub 2006 May 2. |
| 23318282 | Background | Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Discrimination of prohibited oral use from authorized inhaled treatment of budesonide in sports. Ther Drug Monit. 2013 Feb;35(1):118-28. doi: 10.1097/FTD.0b013e3182787b20. |
| 22573060 | Background | Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Identification of budesonide metabolites in human urine after oral administration. Anal Bioanal Chem. 2012 Aug;404(2):325-40. doi: 10.1007/s00216-012-6037-0. Epub 2012 May 10. |
| 17723530 | Background | Spyridaki MH, Kiousi P, Vonaparti A, Valavani P, Zonaras V, Zahariou M, Sianos E, Tsoupras G, Georgakopoulos C. Doping control analysis in human urine by liquid chromatography-electrospray ionization ion trap mass spectrometry for the Olympic Games Athens 2004: determination of corticosteroids and quantification of ephedrines, salbutamol and morphine. Anal Chim Acta. 2006 Jul 28;573-574:242-9. doi: 10.1016/j.aca.2006.04.042. Epub 2006 Apr 27. |
| 17386705 | Background | Touber ME, van Engelen MC, Georgakopoulus C, van Rhijn JA, Nielen MW. Multi-detection of corticosteroids in sports doping and veterinary control using high-resolution liquid chromatography/time-of-flight mass spectrometry. Anal Chim Acta. 2007 Mar 14;586(1-2):137-46. doi: 10.1016/j.aca.2006.09.058. Epub 2006 Oct 5. |
| 18486661 | Result | Andersen JH, Hansen LG, Pedersen M. Optimization of solid phase extraction clean up and validation of quantitative determination of corticosteroids in urine by liquid chromatography-tandem mass spectrometry. Anal Chim Acta. 2008 Jun 9;617(1-2):216-24. doi: 10.1016/j.aca.2008.02.070. Epub 2008 Mar 27. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |