福司列弗多巴/卡比多巴皮下输注与左旋多巴-卡比多巴肠凝胶输送至空肠的暴露量等效。
Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum.
机构信息
Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.
Clinical Pharmacology and Pharmacometrics, AbbVie GmbH & Co KG, Germany.
出版信息
Parkinsonism Relat Disord. 2022 Apr;97:68-72. doi: 10.1016/j.parkreldis.2022.03.012. Epub 2022 Mar 22.
INTRODUCTION
The objective of this study was to compare the pharmacokinetics (PK) of levodopa (LD) from 24-h continuous subcutaneous infusion of foslevodopa/foscarbidopa to the LD pharmacokinetics from 16-h levodopa-carbidopa intestinal gel (LCIG) followed by night-time oral LD/carbidopa (CD) doses.
METHODS
This was a Phase 1, open-label, randomized, 2-period crossover study conducted in 25 male and female healthy volunteers.
RESULTS
The LD exposures (C, AUC and AUC∞) following subcutaneous infusion of 700/35 mg foslevodopa/foscarbidopa over 24 h were similar (<8% difference) to those of LCIG 350/87.5 mg LD/CD administered over 16 h followed by two 100/25 mg LD/CD oral doses at 18 and 21 h after the start of LCIG delivery.
CONCLUSION
Foslevodopa/foscarbidopa subcutaneous infusion provides levodopa exposures comparable to LCIG throughout the day.
GOV IDENTIFIER
Not Applicable.
介绍
本研究的目的是比较左旋多巴（LD）从 24 小时持续皮下输注福司卡比多巴/左旋多巴到 16 小时左旋多巴-卡比多巴肠凝胶（LCIG）后夜间口服左旋多巴/卡比多巴（CD）剂量的药代动力学（PK）。
方法
这是一项在 25 名男性和女性健康志愿者中进行的 1 期、开放标签、随机、2 期交叉研究。
结果
皮下输注 700/35mg 福司卡比多巴/左旋多巴 24 小时后的 LD 暴露量（C、AUC 和 AUC∞）与 LCIG 350/87.5mg LD/CD 相似（<8%差异），LCIG 持续 16 小时后，随后在 LCIG 给药开始后 18 和 21 小时给予两次 100/25mg LD/CD 口服剂量。
结论
福司卡比多巴/左旋多巴皮下输注提供的左旋多巴暴露量与 LCIG 全天相当。
政府标识符
不适用。
Zotero 插件