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Pharmacokinetic and pharmacodynamic similarity evaluation between an insulin glargine biosimilar product and Lantus (R) in healthy subjects: Pharmacokinetic parameters of both parent insulin glargine and M1 were used as endpoints

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成果类型:
期刊论文
作者:
Wang, Yiya;Zhou, Ying;Ding, Juefang;Li, Xianjing;Guo, Fengxue;...
作者机构:
[Li, Xianjing; Wang, Yiya; Ding, Li] China Pharmaceut Univ, Dept Pharmaceut Anal, Nanjing, Peoples R China.
[Wang, Yiya] Nanjing Clin Tech Labs Inc, Nanjing, Peoples R China.
[Zhou, Ying] Beijing Fosun Pharmaceut Technol Dev Co LTD, Beijing, Peoples R China.
[Ding, Juefang] Nanjing Jiening Pharmaceut Technol Co, Nanjing, Peoples R China.
[Guo, Fengxue] Xingtai Med Coll, Second Affiliated Hosp, Xingtai, Peoples R China.
语种:
英文
关键词:
clamp study;Insulin glargine;pharmacokinetics;Pharmacodynamics;Biosimilarity;Biosimilar product
期刊:
Frontiers in Pharmacology
ISSN:
1663-9812
年:
2022
页码:
3181
机构署名:
本校为其他机构
摘要:
Insulin glargine is a long-acting insulin analog, which plays an important role in the treatment of diabetes mellitus. Biosimilar products of insulin glargine can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. This article presents a randomized, double-blind, single-dose, two-treatment, four-period, replicate crossover, euglycemic clamp study which was designed to evaluate the PK and PD similarity between the recombinant insulin glargine developed by Wanbang (test) and Lantus(R) (reference) in healthy volunteers. Subjects rece...

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