Evaluation of pharmacokinetic and pharmacodynamic similarity of an IDegAsp biosimilar versus the originator in healthy Chinese volunteers.

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Tác giả: Xinlei Chen, Li Deng, Linfeng Guo, Wengang He, Kanghua Huang, Li Lan, Hui Liu, Wenjia Wang, Yang Xiong, Hongling Yu, Yerong Yu, Yulei Zhuang

Ngôn ngữ: eng

Ký hiệu phân loại: 627.12 Rivers and streams

Thông tin xuất bản: England : Expert opinion on investigational drugs , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 55490

OBJECTIVES: 22011 is an insulin degludec/insulin aspart co-formulation (IDegAsp) that shares an identical amino acid sequence with Ryzodeg, the originator IDegAsp. This study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of 22,011 with Ryzodeg. METHODS: In a single-center, randomized, open-label, two-treatment, two-period, two-sequence, crossover, euglycemic clamp study, healthy Chinese adults were randomized to receive 0.5 U/kg of 22,011 and Ryzodeg under fasting conditions. PK was evaluated for up to 120 hours and PD (represented by glucose infusion rate [GIR]) was assessed for up to 24 hours. RESULTS: Of 46 subjects randomized, all completed both treatment periods and were included in the PK/PD and safety analysis set. Insulin exposure (AUC CONCLUSION: This study demonstrated the PK/PD similarity of 22,011 to Ryzodeg with a comparable safety profile.
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