Randomized Clinical Trial of the Pharmacodynamics of Lorelin Depot 3.75Mg (Leuprorelin Acetate) Produced by Laboratório Químico Farmacêutico Bergamo LTDA. Compared to Lupron Depot ® 3.75 Mg Produced by Abbott in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Decrease of serum levels of luteinizing hormone, Testosterone and FSH
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test
Lorelin Depot - Bergamo
干预措施: Lorelin Depot Bergamo (Drug)
comparator
Lupron Depot® - Abbott
干预措施: Lupron Depot - Abbott (Drug)
结局指标
主要结局
Decrease of serum levels of luteinizing hormone, Testosterone and FSH
时间窗: 56 days
次要结局
- Evaluation of safety through the adverse affects investigation(56 days)