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Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control

NCT04197622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Hydrochlorothiazide

12,5 mg of hydrochlorothiazide (1/2 tablet of 25 mg) administered orally in a single dose.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Rafael de la Torre Fornell, Dr · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2019-03-21
Completion
2019-03-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197622 on ClinicalTrials.gov