CompletedPhase 1

Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

5 participantsStarted 2016-11-17

Plain-language summary

The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male volunteers aged from 18 to 45 years.
✓. Understanding and accepting the study procedures and signing the informed consent form.
✓. A health profile devoid of organic or physiological disorders.
✓. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
✓. Body mass index (BMI=weigh/height2) will range between 19 and 25 Kg/m2 and weight between 50 and 100 kg. BMI between 25 and 27 kg/m2 can be included by principal investigator criteria.

Exclusion criteria

✕. Non compliance of the inclusion criteria.
✕. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
✕. History of allergy or adverse reactions to any medication.
✕. Subjects for which the drug involved in the study is counter indicated.
✕. History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
✕. History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
✕. Have been volunteer in another study with drugs in the last 3 months prior to start this study.
✕. Have taken part in studies with blood donation in the last 2 months prior to start this study.

What they're measuring

Urine concentrations of leuprorelin acetate

Timeframe: From the administration to 6 hours post-administration

Trial details

NCT IDNCT02920359

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-13

View on ClinicalTrials.gov More There Are no Conditions Under Study. Healthy Volunteers trials