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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
12,5 mg of hydrochlorothiazide (1/2 tablet of 25 mg) administered orally in a single dose.
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-1 urine samples
Time frame: 0-4 hours post-administration
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-2 urine samples
Time frame: 4-8 hours post-administration
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-3 urine samples
Time frame: 8-12 hours post-administration
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-4 urine samples
Time frame: 12-24 hours post-administration
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-5 urine samples
Time frame: 24-36 hours post-administration
Urine concentration of hydrochlorothiazide
Concentration of hydrochlorothiazide in fraction-6 urine samples
Time frame: 36-48 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-1 urine samples
Time frame: 0-4 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-2 urine samples
Time frame: 4-8 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-3 urine samples
Time frame: 8-12 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-4 urine samples
Time frame: 12-24 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-5 urine samples
Time frame: 24-36 hours post-administration
Urine concentration of hydrochlorothiazide metabolites
Concentration of hydrochlorothiazide metabolites (ACB and others) in fraction-6 urine samples
Time frame: 36-48 hours post-administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.