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

Azidus

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Lorelin Depot Bergamo

Drug: Lupron Depot - Abbott

Study type

Interventional

Funder types

Industry

Identifiers

NCT01071005

Versão 03 - Emenda 1

LEUBER0409

Details and patient eligibility

About

The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance.

Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.

Enrollment

58 patients

Sex

Male

Ages

40 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Accept the Informed Consent.
Subjects of research males aged 40 to 45 years;
Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;
Be considered healthy, from the analysis of the clinical history and medical examination;
Laboratory tests with results outside the values considered normal, but not considered clinically relevant.

Exclusion criteria

Have donated or lost 450 mL or more of blood in the three months preceding the study;
Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;
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;
Have been hospitalized for any reason, up to 8 weeks before the study;
Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;
Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
Amendments pressure of any etiology requiring pharmacological treatment;
Present history of myocardial infarction, angina and / or heart failure.