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 range

18 Years – 50 Years

Sex

MALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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