Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

Launched by AZIDUS BRASIL · Feb 17, 2010

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Accept the Informed Consent.
• • 2. Subjects of research males aged 40 to 45 years;
• • 3. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;
• • 4. Be considered healthy, from the analysis of the clinical history and medical examination;
• • 5. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.
• Exclusion Criteria:
• • 1. Have donated or lost 450 mL or more of blood in the three months preceding the study;
• • 2. Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;
• • 3. Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began;
• • 4. Have been hospitalized for any reason, up to 8 weeks before the study;
• • 5. Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;
• • 6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
• • 7. Amendments pressure of any etiology requiring pharmacological treatment;
• • 8. Present history of myocardial infarction, angina and / or heart failure.