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Pharmacokinetic equivalence of CT-P39 and reference omalizumab in healthy individuals: A randomised, double-blind, parallel-group, Phase 1 trial
Clinical and Translational Allergy ( IF 4.4 ) Pub Date : 2022-11-15 , DOI: 10.1002/clt2.12204 Marcus Maurer 1, 2 , Sarbjit S Saini 3 , Kristi McLendon 4 , Paul Wabnitz 5 , Sunghyun Kim 6 , Keumyoung Ahn 6 , Suyoung Kim 6 , Sewon Lee 6 , Clive Grattan 7
Clinical and Translational Allergy ( IF 4.4 ) Pub Date : 2022-11-15 , DOI: 10.1002/clt2.12204 Marcus Maurer 1, 2 , Sarbjit S Saini 3 , Kristi McLendon 4 , Paul Wabnitz 5 , Sunghyun Kim 6 , Keumyoung Ahn 6 , Suyoung Kim 6 , Sewon Lee 6 , Clive Grattan 7
Affiliation
CT-P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT-P39 to European Union-approved and United States-licensed reference omalizumab (EU- and US-omalizumab, respectively).
中文翻译：
CT-P39 和参考奥马珠单抗在健康个体中的药代动力学等效性：一项随机、双盲、平行组、1 期试验
CT-P39正在开发作为参考奥马珠单抗的生物仿制药。本研究旨在评估 CT-P39 与欧盟批准和美国许可的参考奥马珠单抗（分别为欧盟和美国奥马珠单抗）的药代动力学等效性。
更新日期：2022-11-16
中文翻译：
CT-P39 和参考奥马珠单抗在健康个体中的药代动力学等效性：一项随机、双盲、平行组、1 期试验
CT-P39正在开发作为参考奥马珠单抗的生物仿制药。本研究旨在评估 CT-P39 与欧盟批准和美国许可的参考奥马珠单抗（分别为欧盟和美国奥马珠单抗）的药代动力学等效性。
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