Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

Inclusion Criteria

• •1. Healthy male volunteers aged from 18 to 45 years.
• •2. Understanding and accepting the study procedures and signing the informed consent form.
• •3. A health profile devoid of organic or physiological disorders.
• •4. 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.
• •5. 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.
• •2. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
• •3. History of allergy or adverse reactions to any medication.
• •4. Subjects for which the drug involved in the study is counter indicated.
• •5. 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.
• •6. History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
• +11 more criteria