CompletedPhase 1

Generation of Positive Biological Samples to Epoetin for Doping Control.

2 participantsStarted 2016-11-30

Plain-language summary

The study consists of generation of biological samples (in blood and urine) positive to Epoetin alfa for laboratories that wish to perform the analysis of doping controls and maintain accreditation from World Anti-Doping Agency.

Who can participate

Age range18 Years – 50 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 50 years.
✓. 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 27 Kg/m2 and weight between 50 and 110 kg.
✓. Understanding and accepting the study procedures and signing the informed consent form.

Exclusion criteria

✕. Non compliance of the inclusion criteria.
✕. Having suffered any organic disease or major surgery in the three months prior to start this study.
✕. A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment; or 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 psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
✕. History of hypertension, seizures, endocrine disorders (such as diabetes and hypothyroidism), coagulation disorders, kidney and/or liver disease.
✕. Subjects for which the drug involved in the study is counter indicated.
✕. Smokers of more than 20 cigarettes per day.
✕. Taking more than 35 g of alcohol per day.

What they're measuring

Blood and urine concentrations of Epoetin alfa

Timeframe: From 48-72 hours pre-administration to 144 hours post administration

Trial details

NCT IDNCT02920372

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-17

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