Clinical trial NCT03537326: Study to Detect Oral Administration of Budesonide in Women.
Official title: Study to Detect Oral Administration of Budesonide in Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: doping
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 6β-hydroxy-budesonide urine concentration.
timeFrame: 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:
measure: Medication and other metabolites urine concentrations.
timeFrame: 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
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IMIM
Study officials:
affiliation: Laboratorio Antidopaje de Catalunya.
name: Rosa Ventura Alemany, Pharmacéutic
role: PRINCIPAL_INVESTIGATOR
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