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Akademický článek

Comparison of pharmacokinetics and safety between CE-fosphenytoin sodium, fosphenytoin sodium, and phenytoin sodium after intravenous and intramuscular administration in healthy volunteers

Autor: Xiaojiao Li, Min Wu, Jixuan Sun, Weili Jin, Lei Han, Jia Xu, Jingrui Liu, Hong Zhang, Jing Wang, Daidi Wang, Hanyi Zhang, Qing Zhang, Nini Liu, Yanhua Ding

Publikováno v: Frontiers in Pharmacology, Vol 14 (2023)

Background: Captisol®-enabled-fosphenytoin sodium (CE-fosphenytoin sodium) injection is a modified formulation of fosphenytoin sodium.Objective: We aim to compare the intravenous and intramuscular bioavailability and safety between CE-fosphenytoin s

Externí odkaz: https://doaj.org/article/32c43ba8b1ae4c08867dadd615ae284a

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Akademický článek

Solving nonlinear equation systems via clustering-based adaptive speciation differential evolution

Autor: Qishuo Pang, Xianyan Mi, Jixuan Sun, Huayong Qin

Publikováno v: Mathematical Biosciences and Engineering, Vol 18, Iss 5, Pp 6034-6065 (2021)

In numerical computation, locating multiple roots of nonlinear equations (NESs) in a single run is a challenging work. In order to solve the problem of population grouping and parameters settings during the evolutionary, a clustering-based adaptive s

Externí odkaz: https://doaj.org/article/4eacf77d8f504f80a86c42dc480c5dcf

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Akademický článek

A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects

Autor: Hong Zhang, Xiaojiao Li, Jingrui Liu, Cuiyun Li, Min Wu, Xiaoxue Zhu, Jixuan Sun, Min Fang, Yanhua Ding

Publikováno v: Annals of Medicine, Vol 53, Iss 1, Pp 375-383 (2021)

AbstractPurpose QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.Design A randomised, double-blind,

Externí odkaz: https://doaj.org/article/d226eed6d169454286b7c306314fa8f9

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Akademický článek

Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

Autor: Hong Zhang, Min Wu, Jixuan Sun, Xiaoxue Zhu, Cuiyun Li, Yanhua Ding, Xiaodi Zhang, Katherine Chai, Xiaojiao Li

Publikováno v: Pharmacology Research & Perspectives, Vol 9, Iss 2, Pp n/a-n/a (2021)

Abstract The primary objective of this randomized, double‐blind, parallel‐controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy vo

Externí odkaz: https://doaj.org/article/7ebc41ebf7794949a0afe21441bfccbe

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Akademický článek

A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects

Autor: Hong Zhang, Min Wu, Xiaoxue Zhu, Cuiyun Li, Xiaojiao Li, Jixuan Sun, Chengjiao Liu, Quan Liu, Wei Wei, Junqi Niu, Yanhua Ding

Publikováno v: Frontiers in Pharmacology, Vol 11 (2020)

ObjectiveThis study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.MethodsThis is a randomized, double-blind, two-arm, parallel study

Externí odkaz: https://doaj.org/article/8cde9e35029048eda6d9db652e53b3bb

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A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers

Autor: Xiaojiao Li, Katherine Chai, Yanhua Ding, Min Wu, Jixuan Sun, Xiaodi Zhang, Chen Yu, Hongjie Qian, Xiaoxue Zhu

Publikováno v: Cancer Chemotherapy and Pharmacology

Purpose To compare the pharmacokinetic profiles, safety and immunogenicity of proposed bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males. Methods In this double-blind Phase 1 study, healthy volunteers (N = 208) were ran

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::727d2b14e50e3a02ef655e4aa4b3ac47
https://doi.org/10.1007/s00280-021-04297-z

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A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects

Autor: Jingrui Liu, Yanhua Ding, Cuiyun Li, Min Wu, Jixuan Sun, Hong Zhang, Xiaoxue Zhu, Min Fang, Xiaojiao Li

Publikováno v: Annals of Medicine
article-version (VoR) Version of Record

QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects. A randomised, double-blind, two-arm, parallel stud

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::86b13c7ca9712f07e3059aa6405788a8
http://europepmc.org/articles/PMC7919877

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Autor: Min Wu, Katherine Chai, Yanhua Ding, Hong Zhang, Cuiyun Li, Jixuan Sun, Xiaodi Zhang, Xiaoxue Zhu, Xiaojiao Li

Publikováno v: Pharmacology Research & Perspectives, Vol 9, Iss 2, Pp n/a-n/a (2021)
Pharmacology Research & Perspectives

The primary objective of this randomized, double‐blind, parallel‐controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volunteers,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5da74d8b5434b4d3f93929bbe8a8d6c1
https://doi.org/10.1002/prp2.733

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A phase I study of fluzoparib tablet formulation, an oral PARP inhibitor: effect of food on the pharmacokinetics and metabolism after oral dosing in healthy Chinese volunteers

Autor: Hong Chen, Min Wu, Yanhua Ding, Jixuan Sun, Xiaojiao Li

Publikováno v: Expert opinion on drug metabolismtoxicology. 17(4)

To evaluate the effect of food on the pharmacokinetics (PK) of fluzoparib capsule.PK data were obtained after fluzoparib treatment in a crossover design study. Single-dose fluzoparib (120 mg) was administered under fasted and fed conditions to 16 hea

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::054703e49f17f03221f9d52e168b4a9d
https://pubmed.ncbi.nlm.nih.gov/33535835

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A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects

Autor: Hong Zhang, Min Wu, Jinchen Yu, Yanhua Ding, Dandan Wu, Jin Wei, Zhaohe Wang, Jia Xu, Shengfeng Li, Jixuan Sun

Publikováno v: Expert opinion on investigational drugs. 30(1)

Background: To compare the pharmacokinetic (PK) profile, safety, and immunogenicity between golimumab and the biosimilar BAT2506 in healthy Chinese male subjects. Research design and methods: A tot...

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2ef3b1233ca4ee0d6541f91ac53614c6
https://pubmed.ncbi.nlm.nih.gov/33241960

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