Healthy Volunteers Clinical Trial
Official title:
Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control
Background:
Androgens are used for doping purpose because they can increase muscle mass and strength.
These drugs are included in the list of prohibited substances of the World Anti-Doping Agency
(WADA). The prohibition of its use has given rise to a great variety of strategies, including
indirect androgenic doping (increasing endogenous testosterone production) or masking of
exogenous testosterone administration.
Fluconazole is an imidazole antifungal that inhibits certain cytochrome P-450 dependent
enzymes participating in the synthesis of steroid hormones. Concomitant fraudulent
administration of testosterone and fluconazole may cause lower steroid concentrations in
urine, leading to false negatives in the doping control. Thus, fluconazole may be used in
athletes to mask exogenous steroid administration.
Hypothesis:
The oral administration of 12,5 mg of hydrochlorothiazide in healthy subjects allows
generating detectable concentrations of the drug in urine. Positive urine samples will enable
to identify analytical strategies for doping control.
Objectives:
Primary objective: To measure the concentrations of fluconazole in urine for anti-doping
control samples.
Secondary objectives: To identify fluconazole metabolites in urine. To explore the time
window in which the drug or its metabolites can be detected in urine after administration. To
assess safety and tolerability of the drug used.
Methods:
Phase I, open, non-randomized clinical trial, with a treatment condition (fluconazole)
administered in a single oral dose to 2 subjects.
n/a
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