Study to Detect Oral Administration of Budesonide in Women.

NCT03537326 | Completed Phase 1

• 2 other identifiers: IMIMFTCL/DACORSIN/32017-004839-37
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

doping

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Medication and other metabolites urine concentrations.

  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

Study Arms (1)

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.

Drug: Budesonide

Interventions

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 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.

Also known as: Entocord® modified release capsule, 3 mg single-dose

Budesonide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female volunteers aged from 18 to 45 years.
• Understand and accepting the procedures of the trial and sign an informed consent.
• Have a history and physical exams that show that there is no organic or psychiatric problems.
• The ECG, and the general blood and urine analyses done before the trial, have to be in the normal limits. Punctual or minor variations outside limits could be accepted if, according to the Main Investigator and regarding the state of science, they don't have clinical impact, can't present a risk for the subjects and don't interfere in the medication evaluation. These variations and their non-relevance will be specifically justified in writing.
• The subjects must weigh between 50 and 75kg, with a BMI between 19 and 27 kg/m2.

You may not qualify if:

• Have a medical history of allergy, idiosyncrasy, hypersensibility or adverse reactions to corticoids or the medication excipients. Have a medical history of serious adverse reaction to some medication.
• Subjects with contraindication to treatments with the trial's medication (according to the respective data sheet).
• Medical history or clinical evidence of gastrointestinal, hepatic or renal issue; or other types of issue that could suppose a deterioration of medication abortion, distribution, metabolism or excretion, or that could suggest gastrointestinal irritation by any medication.
• Medical history or clinical evidence of issue that would be psychiatric, alcoholism, medication or drugs abuse, or usual consumption of psychoactive medication.
• Participate in a clinical trial involving medication in the last 3 months before the beginning of the trial.
• Have done a blood donation during the last 3 months preceding of the study, if it's necessary to draw blood for the study.
• Have suffered from an organic illness or major emergency during the 6 months preceding the trial.
• Medical history or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematologic or neurologic disease; or other acute or chronic illness that, according to the Main Investigator or collaborators designated by him, could present a risk for the subjects or interfere in the study objectives. Especially osteoporosis, high blood pressure, Cushing syndrome, diabetes mellitus and viral infections such as herpes or varicella.
• Smoke more than 20 cigarets per day during the last 3 months before the study.
• Consume more than 20g of alcohol per day.
• Consume more than 5 cafés, teas, cola drinks or other stimulating drinks or with xanthine per day in the 3 months preceding the start of the study.
• Not being able to understand the nature of the study and procedures that it implies to follow.
• Have a positive serology for B or C hepatitis or HIV.
• Being pregnant or breastfeeding and don't use reliable means of contraception during the study.
• Take hormonal contraceptives (oral, topic, injectable or vaginal).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

IMIM

Barcelona, 08003, Spain

Location

Related Publications (11)

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  PMID: 8563509 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.

  PMID: 15634032 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.

  PMID: 12955741 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.

  PMID: 17689473 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.

  PMID: 11554422 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.

  PMID: 16631183 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.

  PMID: 23318282 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.

  PMID: 22573060 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.

  PMID: 17723530 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.

  PMID: 17386705 BACKGROUND

• 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.

  PMID: 18486661 RESULT

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Rosa Ventura Alemany, Pharmacéutic

  Laboratorio Antidopaje de Catalunya.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacologist (Md)

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: May 22, 2018
• Primary Completion: July 1, 2018
• Study Completion: September 10, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)