Healthy Volunteers Clinical Trial
Official title:
Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control
Background:
Hydrochlorothiazide is a diuretic that inhibits the reabsorption of sodium and chloride in
the renal tubules, thus increasing the excretion of water.
The use of hydrochlorothiazide in athletes is prohibited by the World Anti-Doping Agency. Its
fraudulent administration can lead to significant acute weight losses (body water reduction)
and can mask the use of other doping substances, since it increases the urine volume and
alters its pH (false negatives).
The main degradation product of hydrochlorothiazide is
4-amino-6-chloro-1,3-benzenedisulfonamide (ACB). ACB is detectable in urine for a longer time
and in a greater concentration than hydrochlorothiazide. This suggests that ACB may be an
important marker for the detection of hydrochlorothiazide doping.
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 hydrochlorothiazide in urine for
anti-doping control samples.
Secondary objectives: To identify hydrochlorothiazide 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
(hydrochlorothiazide) administered in a single oral dose to 3 subjects.
n/a
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