Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal