Healthy Volunteers Clinical Trial
Official title:
Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control
Background:
Hydromorphone (HM) is a semi-synthetic derivative of morphine used for pain control. Like
other opiates, due to its high potential of abuse HM is included on the World Anti-Doping
Agency (WADA) list of prohibited substances.
Hypothesis:
The oral administration of hydromorphone hydrochloride 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 hydromorphone in urine for anti-doping
control samples.
Secondary objective: To identify metabolites and precursors of hydromorphone in urine. To
assess safety and tolerability of the drug used.
Methods:
Phase I, open, non-randomized clinical trial, with a treatment condition (hydromorphone)
administered orally to 2 subjects.
This study aims to characterize the patterns of urinary excretion of HM following the oral administration of 4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone). The detection of HM consumption can be done by urine immunoassay but several immunoassay tests are required to thoroughly detect synthetic, semi-synthetic and natural opioids due to the limited cross-reactivity of each assay. Therefore, superior test strategies are required to specifically identify low concentrations of opioids. ;
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