A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers

被引:0
|
作者
Takashi Eto
Yuji Karasuyama
Verónica González
Ana Del Campo García
机构
[1] Souseikai Hakata Clinic,Clinical Research Unit
[2] Syneos Health Clinical K.K.,Medical Department
[3] mAbxience Research S.L.,undefined
来源
关键词
MB02; Bevacizumab; Biosimilars; Pharmacokinetics; Safety; Japanese;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:713 / 722
页数:9
相关论文
共 50 条
  • [21] A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects
    Lee, Hyun A.
    Kim, Sujung
    Seo, Hyoryeong
    Kim, Soyeon
    EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2023, 32 (10) : 959 - 966
  • [22] A phase I, randomized, single-dose study evaluating the pharmacokinetic equivalence of biosimilar ABP 215 and bevacizumab in healthy adult men (vol 80, pg 755, 2017)
    Markus, Richard
    Chow, Vincent
    Pan, Zhiying
    Hanes, Vladimir
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2018, 81 (02) : 419 - 419
  • [23] A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar
    Wang, Yanli
    Liu, Zhengzhi
    Deng, Qiaohuan
    Su, Zhengjie
    Xue, Jinling
    Zhao, Yicheng
    Yang, Haimiao
    EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, 2023, 19 (11) : 849 - 855
  • [24] A Randomized, Single-Dose, Parallel-Controlled Phase I Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers
    Cheng, Jie
    Wang, Chenguang
    Xu, Jin
    Zhao, Chunyang
    Song, Rong
    Wang, Yijun
    Zou, Yang
    Zhang, Xunmin
    Shan, Yong
    Zhou, Jian
    Jia, Jing-Ying
    CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2024, 13 (04): : 349 - 359
  • [25] A single-dose, randomized, open-label, four-period, crossover equivalence trial comparing the clinical similarity of the proposed biosimilar rupatadine fumarate to reference Wystamm® in healthy Chinese subjects
    Lin, Sisi
    Lou, Yutao
    Hao, Rui
    Shao, Yiming
    Yu, Jin
    Fang, Lu
    Bao, Meihua
    Yi, Wu
    Zhang, Yiwen
    FRONTIERS IN PHARMACOLOGY, 2024, 15
  • [26] A RANDOMIZED PHASE 1 STUDY EVALUATING THE PHARMACOKINETIC EQUIVALENCE OF PROPOSED BIOSIMILAR HLX14 AND DENOSUMAB IN HEALTHY CHINESE VOLUNTEERS.
    Zhang, J.
    Wu, X.
    Zhang, X.
    Zhou, L.
    Kang, W.
    Zhu, J.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2022, 111 : S59 - S59
  • [27] Single-dose pharmacokinetic study of ciprofloxacin and fleroxacin in healthy adult Nigerian volunteers
    Chukwuani, CM
    Coker, HAB
    Oduola, AMJ
    Ifudu, ND
    Sowunmi, A
    CHEMOTHERAPY, 1998, 44 (06) : 369 - 376
  • [28] Rectal and sublingual administration of tacrolimus: a single-dose pharmacokinetic study in healthy volunteers
    Stifft, Frank
    Vanmolkot, Floris
    Scheffers, Ingrid
    van Bortel, Luc
    Neef, Cees
    Christiaans, Maarten
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2014, 78 (05) : 996 - 1004
  • [29] A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers
    Raykova, Ekaterina
    Farahani, Mohammad Farmahini
    Ivanova, Stanislava
    Azhdarzadeh, Morteza
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2022, 22 (02) : 235 - 243
  • [30] A Phase I, Randomized, Single-Dose Study Evaluating the Biosimilarity of TAB008 to Bevacizumab in Healthy Volunteers
    Wang, Jin
    Qi, Lu
    Liu, Long
    Wang, Zejuan
    Chen, Gang
    Wang, Yu
    Liu, Xiaona
    Liu, Ying
    Liu, Huijuan
    Tong, Yuanxu
    Liu, Chen
    Lei, Chunpu
    Wang, Xinghe
    FRONTIERS IN PHARMACOLOGY, 2019, 10