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

September 10, 2018 updated by: Julian Mateus, Parc de Salut Mar
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • IMIM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Entocord® modified release capsule, 3 mg single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Rosa Ventura Alemany, Pharmacéutic, Laboratorio Antidopaje de Catalunya.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 10, 2018

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIMFTCL/DACORSIN/3
  • 2017-004839-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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