دورية أكاديمية
Population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (recombinant exendin-4, rE-4) in Chinese patients with type 2 diabetes mellitus
| العنوان: | Population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (recombinant exendin-4, rE-4) in Chinese patients with type 2 diabetes mellitus |
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| المؤلفون: | Zang, Yan-Nan, Zhang, Min-Jie, Wang, Yi-Tong, Wang, Chen, Wang, Qian, Zheng, Qing-Shan, Ji, Li-Nong, Guo, Wei, Fang, Yi |
| المساهمون: | Guo, W (reprint author), Capital Med Univ, Beijing Anding Hosp, Beijing Key Lab Mental Disorders, Dept Pharm, 5 Ankang Lane,Dewai Ave, Beijing 100088, Peoples R China., Fang, Y (reprint author), Peking Univ Peoples Hosp, Dept Pharm, 11,Xizhimen South St, Beijing 100044, Peoples R China., Capital Med Univ, Beijing Anding Hosp, Beijing Key Lab Mental Disorders, Dept Pharm, 5 Ankang Lane,Dewai Ave, Beijing 100088, Peoples R China., Peking Univ Peoples Hosp, Dept Pharm, 11,Xizhimen South St, Beijing 100044, Peoples R China., Shanghai Univ Chinese Med, Ctr Drug Clin Res, Shanghai, Peoples R China., Peking Univ Peoples Hosp, Dept Endocrinol & Metab, Beijing, Peoples R China. |
| المصدر: | SCI |
| بيانات النشر: | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS |
| سنة النشر: | 2017 |
| المجموعة: | Peking University Institutional Repository (PKU IR) / 北京大学机构知识库 |
| مصطلحات موضوعية: | lyophilized recombinant glucagon-like peptide-1 receptor agonist (recombinant exendin-4, rE-4), population pharmacokinetics, two-compartment model, LIRAGLUTIDE PHARMACOKINETICS, EXENATIDE, MODEL, RATS |
| الوصف: | Objective: To investigate the population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (rE-4) in Chinese patients with type 2 diabetes mellitus (T2DM) for plasma concentration estimation and individualized treatment. Methods: Twelve patients with T2DM were enrolled to receive subcutaneous injections of rE-4 at 5 mu g twice daily for 84 days. Administration dosage was adjusted from 5 mu g to 10 mu g twice daily at day 29 in case of glycated albumin (GA) >= 17%. The population pharmacokinetic model was developed in the nonlinear mixed-effects modeling software NONMEM. Results: The data were best described by a two-compartment model with first-order absorption and elimination. The outcome parameters were as follows: apparent clearance (CL/F) 6.67 L/h, apparent distribution volume of central compartment (V-c/F) 19.4 L, absorption rate constant (K-a) 1.39 h(-1), apparent distribution volume of peripheral compartment (V-p/F) 22.6 L, intercompartmental clearance (Q/F) 1.28 L/h. The interindividual variabilities for CL/F, V-c/F, K-a, and Q/F were 64.4%, 57.7%, 45.5%, and 153.3%, respectively. The intra-individual variability of proportional error model was 41.7%. No covariate was screened out that showed significant influence on the model parameters. Conclusions: The established two-compartment model with first-order absorption and elimination successfully described the pharmacokinetic characteristics of rE-4 in Chinese patients with T2DM. ; Major Project of National Science and Technology [2012ZX09303019]; Beijing Science and Technology Plan Project [Z151100004015180]; Beijing Anding Hospital [YRG201508] ; SCI(E) ; ARTICLE ; 8 ; 650-658 ; 55 |
| نوع الوثيقة: | journal/newspaper |
| اللغة: | English |
| تدمد: | 0946-1965 |
| العلاقة: | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS.2017,55(8),650-658.; 1905875; http://hdl.handle.net/20.500.11897/471775Test; WOS:000406517100003 |
| DOI: | 10.5414/CP202973 |
| الإتاحة: | https://doi.org/20.500.11897/471775Test https://doi.org/10.5414/CP202973Test https://hdl.handle.net/20.500.11897/471775Test |
| رقم الانضمام: | edsbas.DC898F53 |
| قاعدة البيانات: | BASE |
| تدمد: | 09461965 |
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| DOI: | 10.5414/CP202973 |