Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).
详细描述
Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
- •Research subjects were male, aged between 18 and 32 years;
- •Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
- •Considered healthy subjects, both clinical and laboratory.
排除标准
- •Have donated or lost 450 mL or more blood in the 6 months preceding the study;
- •Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- •Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
- •Present history of alcohol abuse, drug or drugs;
- •Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
- •Have made previous use of somatropin;
- •Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).
研究组 & 干预措施
Somatropin Test
Somatropin of Blausiegel Indústria e Comércio Ltda.
干预措施: Somatropin (Drug)
Saizen
Somatropin of Merck Serono
干预措施: Somatropin (Drug)
结局指标
主要结局
The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.
时间窗: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.
Pharmacokinetic evaluation will be based on data obtained from the average dosage of somatropin plasma. Thus, the time of collection facilities provide the pharmacokinetic parameters AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2, which will be compared between the two formulations. The quantification of serum somatropin kit will be performed by ELISA validated using human serum as a biological matrix. The evaluation of the pharmacodynamics will be performed by quantifying serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.
次要结局
- After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin.(15 weeks)