Generation of Positive Biological Samples to Epoetin for Doping Control.
NCT ID: NCT02920372
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2016-11-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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EPOETIN ALFA
EPOETIN ALFA
Interventions
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EPOETIN ALFA
Eligibility Criteria
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Inclusion Criteria
2. A health profile devoid of organic or physiological disorders.
3. 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.
4. Body mass index (BMI=weigh/height2) will range between 19 and 27 Kg/m2 and weight between 50 and 110 kg.
5. Understanding and accepting the study procedures and signing the informed consent form.
2. Having suffered any organic disease or major surgery in the three months prior to start this study.
3. 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.
4. History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
5. History of hypertension, seizures, endocrine disorders (such as diabetes and hypothyroidism), coagulation disorders, kidney and/or liver disease.
6. Subjects for which the drug involved in the study is counter indicated.
7. Smokers of more than 20 cigarettes per day.
8. Taking more than 35 g of alcohol per day.
9. Drinking more than 5 drinks containing xanthines per day.
10. Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
11. Have taken part in studies with blood donation in the last 8 weeks prior to start this study.
12. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any excipients.
13. Have been volunteer in another study with drugs in the last 3 months prior to start this study.
14. Subjects with positive serology for hepatitis B, C or HIV.
15. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
18 Years
50 Years
MALE
Yes
Sponsors
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Parc de Salut Mar
OTHER
Responsible Party
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Rafael de la Torre
PhD
Other Identifiers
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2016-002866-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMIMFTCL/EPO
Identifier Type: -
Identifier Source: org_study_id