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

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

doi:10.1002/prp2.733

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

Pharmacology Research & Perspectives ◽

10.1002/prp2.733 ◽

2021 ◽

Vol 9 (2) ◽

Author(s):

Hong Zhang ◽

Min Wu ◽

Jixuan Sun ◽

Xiaoxue Zhu ◽

Cuiyun Li ◽

...

Keyword(s):

Phase 1 ◽

Phase 1 Study ◽

Double Blind ◽

Male Volunteers ◽

Healthy Chinese ◽

Chinese Male

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A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Effects of Food on the Pharmacokinetics of a Single Oral Dose of a 15-mg Tylerdipine Tablet in Healthy Chinese Male Volunteers

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.622 ◽

2018 ◽

Vol 8 (1) ◽

pp. 126-132

Author(s):

Lu Wang ◽

Lijun Xie ◽

Sufeng Zhou ◽

Yuanyuan Wang ◽

Juan Chen ◽

...

Keyword(s):

Oral Dose ◽

Single Oral Dose ◽

Phase 1 ◽

Open Label ◽

Phase 1 Study ◽

Male Volunteers ◽

Crossover Phase ◽

Healthy Chinese ◽

Chinese Male

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A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers

Expert Opinion on Biological Therapy ◽

10.1080/14712598.2021.1944097 ◽

2021 ◽

Author(s):

Yanli Wang ◽

Zhenyue Gao ◽

Zhengzhi Liu ◽

Guangwen Liu ◽

Xinyao Qu ◽

...

Keyword(s):

Single Dose ◽

Clinical Study ◽

Phase I ◽

Double Blind ◽

Male Volunteers ◽

Healthy Chinese ◽

Chinese Male

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Faculty Opinions recommendation of Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725571445.793536699 ◽

2017 ◽

Author(s):

Ian Beales

Keyword(s):

Phase 1 ◽

Anticoagulant Effect ◽

Healthy Male ◽

Double Blind ◽

Phase 1 Trial ◽

Healthy Male Volunteers ◽

Male Volunteers

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Bioequivalence Analysis of 2 Dapoxetine Hydrochloride Formulations in Healthy Chinese Male Volunteers Under Fed and Fasting Conditions: A Randomized, Open‐Label, 2‐Sequence, 2‐Period, 2‐Way Crossover Study

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.866 ◽

2021 ◽

Author(s):

Keyu Yan ◽

Gehang Ju ◽

Qiong Tan ◽

Lijiao Zeng ◽

Wen Qiu

Keyword(s):

Crossover Study ◽

Open Label ◽

Male Volunteers ◽

Period 2 ◽

Healthy Chinese ◽

Chinese Male ◽

Dapoxetine Hydrochloride

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Relative bioavailability of two formulations of nevirapine 200-mg tablets in healthy Chinese male volunteers: A single-dose, randomized-sequence, open-label, two-way crossover study

Clinical Therapeutics ◽

10.1016/s0149-2918(10)80028-1 ◽

2010 ◽

Vol 32 (13) ◽

pp. 2258-2264 ◽

Cited By ~ 1

Author(s):

Yubing Zhu ◽

Qian Zhang ◽

Cuixia Yu ◽

Jianjun Zou ◽

Xiaohong Yang ◽

...

Keyword(s):

Single Dose ◽

Crossover Study ◽

Relative Bioavailability ◽

Open Label ◽

Male Volunteers ◽

Healthy Chinese ◽

Chinese Male

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Pharmacokinetics and Bioequivalence Study of Two Cetirizine Hydrochloride Formulations in Healthy Chinese Male Volunteers

Arzneimittelforschung ◽

10.1055/s-0031-1296422 ◽

2011 ◽

Vol 59 (09) ◽

pp. 440-444

Author(s):

Feng-Guo Xu ◽

Ying Liu ◽

Zun-Jian Zhang ◽

Yuan Tian ◽

Yun Chen

Keyword(s):

Bioequivalence Study ◽

Male Volunteers ◽

Cetirizine Hydrochloride ◽

Healthy Chinese ◽

Chinese Male

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Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial

Advances in Therapy ◽

10.1007/s12325-020-01548-y ◽

2020 ◽

Author(s):

Aixin Shi ◽

Panpan Xie ◽

Lasse Lykke Nielsen ◽

Trine Vang Skjøth ◽

Xuemei He ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Phase 1 ◽

Double Blind ◽

Randomized Controlled ◽

Healthy Chinese ◽

Chinese Subjects

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FRI0421 A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of ct-p13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the planetas study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2013-eular.1548 ◽

2013 ◽

Vol 72 (Suppl 3) ◽

pp. A516.2-A517 ◽

Cited By ~ 11

Author(s):

W. Park ◽

J. Jaworski ◽

J. Brzezicki ◽

A. Gnylorybov ◽

V. Kadinov ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Phase 1 ◽

Phase 1 Study ◽

Double Blind ◽

Safety And Efficacy ◽

Parallel Group

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Effect of Fluconazole on the Pharmacokinetic Properties of Imrecoxib, a Novel NSAID: A Single-center, Open-label, Self-controlled Study in Healthy Chinese Male Volunteers

Clinical Therapeutics ◽

10.1016/j.clinthera.2018.06.009 ◽

2018 ◽

Vol 40 (8) ◽

pp. 1347-1356 ◽

Cited By ~ 2

Author(s):

Cheng-zi Zuo ◽

Yi Gong ◽

Xiang-yu Hou ◽

Yi-fan Zhang ◽

Wen-xing Peng ◽

...

Keyword(s):

Controlled Study ◽

Single Center ◽

Open Label ◽

Male Volunteers ◽

Pharmacokinetic Properties ◽

Healthy Chinese ◽

Chinese Male

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A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti–Zika Virus Vaccine

Annals of Internal Medicine ◽

10.7326/m20-5306 ◽

2021 ◽

Author(s):

Nadine C. Salisch ◽

Kathryn E. Stephenson ◽

Kristi Williams ◽

Freek Cox ◽

Leslie van der Fits ◽

...

Keyword(s):

Virus Vaccine ◽

Zika Virus ◽

Phase 1 ◽

Phase 1 Study ◽

Double Blind

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