The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

开始日期2019-12-10

申办/合作机构

北京医院

100 项与 N11005 相关的临床结果

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100 项与 N11005 相关的转化医学

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100 项与 N11005 相关的专利（医药）

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项与 N11005 相关的文献（医药）

2023-01-01·Frontiers in endocrinology

Pharmacokinetics, pharmacodynamics, and safety of prandial oral insulin (N11005) in healthy subjects.

Article

作者: Wang, Xiaoxia ; Zhuang, Yulei ; Hong, Juan ; Guo, Lixin ; Li, Wenjia ; Hao, Wei-Hua ; Huang, Yuhui ; Pan, Qi ; Zhou, Qinghong ; Wang, Wenjia ; Chen, Xiaofeng ; Zhou, Yijie ; Lan, Li ; Wang, Zhijie ; Yang, Yu-Tsai

AimsTo verify whether the oral insulin N11005 is administered as a prandial insulin by assessing the pharmacokinetics (PK), pharmacodynamics (PD), and safety profiles of N11005 with a short-acting biosynthetic human insulin (Novolin R) as reference.MethodsThis was a randomized, open-label, single-dose, crossover hyperinsulinemic-euglycemic clamp study in healthy Chinese male subjects. A total of 12 subjects were enrolled in the test (T) group (N11005, 300 IU, p.o.) and the reference (R) group (Novolin R, 0.1 IU/Kg, i.h.) with a washout period of 14 days. All subjects were administered on the same day of the clamp study. Glucose Infusion Rates (GIR), serum insulin, and C-peptide concentration were determined during every 8-hour clamp cycle. Trial registration: Clinicaltrials.gov identifier NCT04975022.ResultsAfter administration, the ratios of mean serum C-peptide concentration to baseline concentration in both T and R groups were lower than 50%, which confirmed the stability of the clamp platform. T group (N11005) showed a more rapid onset of action (tGIR_10%max≈11 min) and a comparable duration of action to the R group, which was basically in line with the characteristics of prandial insulins. No adverse events (AEs) occurred throughout the study, which demonstrated that N11005 and Novolin R are safe and well-tolerated.ConclusionsThe PD profiles of the single-dose N11005 in the human body are similar to those of prandial insulins, with an excellent safety profile.Clinical trial registrationClinicaltrials.gov, identifier NCT04975022.

100 项与 N11005 相关的药物交易

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