NCT00913250已完成1 期
A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 96
- 主要终点
- To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
研究概览
简要总结
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
排除标准
- •History of severe allergic or anaphylactic reactions
- •History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.
- •Known allergy to dry natural rubber
- •History of seizure disorder or unexplained blackouts
- •History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
- •Other inclusion and exclusion criteria apply as per protocol
研究组 & 干预措施
Sequence 1
Experimental
Serum containing Avonex followed by serum free Avonex
干预措施: Serum containing Avonex (Drug)
Sequence 2
Experimental
Serum free Avonex followed by serum containing Avonex
干预措施: Serum Free Avonex (Drug)
结局指标
主要结局
To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
时间窗: Study duration is 72 days
次要结局
未报告次要终点
研究者
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