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在健康成年人中,用无针自动注射器ZENEO®进行肌肉内注射的米达佐拉姆的相对生物利用性研究
Olivier Lacombe1, Yannick Pletan2, Jean-Marie Grouin3
1CROSSJECT SA, 6 rue Pauline Kergomard, 21000, Dijon, France. o.lacombe@crossject.com.
Neurology and therapy
|May 28, 2024
概括
通过无针自动注射器进行肌肉内注射的米达佐拉姆与用于治疗状态的传统针头注射具有生物等价性. 这种新的设备在紧急情况下提供更快的管理和潜在的更快的发作终止.
科学领域:
- 药理动力学 药理动力学
- 药物输送系统 药物输送系统
- 紧急医疗 紧急医疗
背景情况:
- 肌肉内注射的米达佐拉姆对于治疗状态至关重要.
- 快速施用至关重要,以防止发作并发症.
- 将无针装置与传统方法进行比较是有效的交付所必需的.
研究的目的:
- 为了比较通过无针自动注射器 (ZENEO®) 给药的肌肉内米达佐拉姆的生物可用性和生物等价性,与传统的注射器和针相比.
- 为了评估无针自动注射器在不同给药环境中的性能 (裸体皮肤与穿着衣服,大腿与腹关节区域).
主要方法:
- 一项在健康成年人中进行的开放标签,随机,四期交叉研究.
- 在禁食条件下,单次10毫克肌肉内注射米达佐拉姆剂量.
- 在36小时内确定了药理动力学概况,分析了AUC0-t,AUC0-∞和Cmax.
主要成果:
- 无针自动注射器在AUC参数方面与传统注射器证明了生物等价性.
- 在大多数比较中,Cmax的生物等价性得到满足,但在通过服装给药时略有误差.
- 自动注射器的早期血度 (前10分钟) 更高,这表明吸收速度更快.
结论:
- 使用ZENEO®自动注射器在赤裸的皮肤上肌肉内注射米达佐拉姆是与传统的针头注射生物相当的.
- 该设备显示可接受的相对生物可用性,可用于各种情况下的紧急使用.
- 较快的注射和较高的初始血度表明可能更快地终止发作.
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