Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: A randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study

Expert Review of Clinical Immunology

Volumn 11, Issue , 2015, Pages S25-S31

  Park, Won ^a   Lee, Sang Joon ^b   Yun, Jihye ^b   Yoo, Dae Hyun ^c  

^a Inha University Hospital   (South Korea)

^b Celltrion Inc   (South Korea)

^c Hanyang University Hospital for Rheumatic Diseases   (South Korea)

Author keywords

biosimilar; CT P13; European Union; healthy subjects; infliximab; pharmacokinetics; safety; USA

Indexed keywords

ALANINE AMINOTRANSFERASE; BIOSIMILAR AGENT; INFLIXIMAB; ANTIRHEUMATIC AGENT; CT-P13; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ACUTE CHOLECYSTITIS; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; EUROPEAN UNION; FATIGUE; FEMALE; FLATULENCE; HEADACHE; HERPETIC STOMATITIS; HUMAN; HUMAN EXPERIMENT; HUMERUS FRACTURE; MALE; MEAN RESIDENCE TIME; NORMAL HUMAN; OROPHARYNX PAIN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; UNITED STATES; VOLUME OF DISTRIBUTION; ADOLESCENT; CLINICAL TRIAL; DRUG APPROVAL; EUROPE; METABOLIC CLEARANCE RATE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; AREA UNDER CURVE; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; DRUG APPROVAL; EUROPE; FEMALE; HEALTHY VOLUNTEERS; HUMANS; INFLIXIMAB; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 84942237438     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2015.1090311     Document Type: Article

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