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Study to Detect Oral Administration of Budesonide in Women. (WADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537326
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Julian Mateus, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE May 22, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
6β-hidroxi-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 Entoncord®, urine sample will be collected by the subjects and then analysed to determine 6β-hidroxi-budesonide concentration.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Medication and other metabolits urine concentration [ 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 Entoncord®, urine sample will be collected by the subjects and then analysed to determine concentrations of Endoncord® and other metabolits of budesonide.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Detect Oral Administration of Budesonide in Women.
Official Title  ICMJE Study to Detect Oral Administration of Budesonide in Women.
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Healthy
Intervention  ICMJE 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.
Other Name: Entocord® modified release capsule, 3 mg single-dose
Study Arms  ICMJE Experimental: Budesonide
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.
Intervention: Drug: Budesonide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)
10
Actual Study Completion Date  ICMJE September 10, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Don't fulfilling one or several inclusion criteria.
  • 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.
  • Having regularly taken medication during the month preceding the study, excepted vitamins, herbal medication or dietetics complementation that, according to the Main Investigator or collaborators designated by him, could present a risk for the subjects or interfere in the study objectives. The intake of a single-dose symptoms medication during the previous week will not be an exclusion criterion if it is considered as completely eliminated the day beginning the experimental session.
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537326
Other Study ID Numbers  ICMJE IMIMFTCL/DACORSIN/3
2017-004839-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julian Mateus, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rosa Ventura Alemany, Pharmacéutic Laboratorio Antidopaje de Catalunya.
PRS Account Parc de Salut Mar
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP