Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a (Rebif - Merck Serono) In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).
详细描述
Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Accepted Informed Consent
- •Study subjects male, aged 18 to 50 years;
- •Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
- •Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.
排除标准
- •Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
- •Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
- •Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
- •Have been hospitalized for any reason, up to 8 weeks before the start of the study;
- •Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
- •Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
- •To present the pressure of any etiology requiring pharmacological treatment;
- •Display history of myocardial infarction, angina and / or heart failure.
结局指标
主要结局
Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
时间窗: 168 hours
Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
次要结局
- Security: observation of adverse effects(168 hours)