甲基酸多相释放片:在禁食和食条件下使用的两种配方之间的生物等价性评估
Marcelo Gomes Davanço1, Jessica Meulman1, Thalita Martins da Silva1
1Medical Department, Adium S.A., São Paulo 04794-000, SP, Brazil.
Pharmaceutics
|June 28, 2023
概括
这项研究发现,Consiv®,一种新的甲基化延长释放片,与Concerta®具有生物相当性. 这意味着Consiv®可以与Concerta®交替使用,用于治疗注意力缺陷/多动障碍 (ADHD).
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 监管科学 监管科学
背景情况:
- 甲基酸是跨年龄组注意力缺陷/多动障碍 (ADHD) 的关键治疗方法.
- 延长释放配方旨在优化药物输送,特别是在学校时间为儿科患者提供.
- 评估生物等价性对于获得监管批准和确保治疗互换性至关重要.
研究的目的:
- 与参考产品 (Concerta®) 相比,评估一种新的甲基化54毫克延长释放片 (Consiv®) 与参考产品 (Concerta®) 的生物等价性.
- 为了满足巴西对药品注册的严格生物等价性要求.
- 确认在禁食和食条件下测试和参考配方之间的治疗互换性.
主要方法:
- 两项独立的,开放的,随机的,单剂量,两期的交叉生物等价性研究在健康的成年人中进行.
- 参与者在禁食和食条件下接受了测试 (Consiv®) 或参考 (Concerta®) 配方,并有7天的洗期.
- 用经过验证的LC-MS/MS方法量化血甲基酸度,并分析了药理动力学参数.
主要成果:
- 关键药理学参数 (Cmax,AUC0-t,AUC0-inf,部分AUC) 的90%置信区间在禁食和食研究中的监管接受范围为80.00%至125.00%.
- 在两个测试条件下,测试配方 (Consiv®) 与参考配方 (Concerta®) 证明了生物等价性.
- 两种甲基化配方都被发现是安全的,并在单剂量后得到良好耐受.
结论:
- 甲基化延长释放54毫克片 (Consiv®) 与Concerta®具有生物相当性.
- 在ADHD治疗的临床实践中,Consiv®可以与Concerta®互换,符合巴西的监管标准.
- 该研究证实了Consiv®在单剂量使用后的安全性和耐受性.
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