A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01)

British Journal of Clinical Pharmacology

Volumn 78, Issue 6, 2014, Pages 1281-1290

  Yin, Donghua ^a   Barker, Kerry B ^a   Li, Ruifeng ^a   Meng, Xu ^a   Reich, Steven D ^a   Ricart, Alejandro D ^a,b   Rudin, Dan ^a   Taylor, Carrie T ^a,c   Zacharchuk, Charles M ^a   Hansson, Arne G ^a,c  

^a PFIZER INC   (United States)

^b Instituto de Oncologia Angel H Roffo   (Argentina)

^c Oncology Clinical Research Pfizer Inc ^*  (United States)

Author keywords

Biosimilar; Immunogenicity; PF 05280014; Pharmacokinetics; Safety; Trastuzumab

Indexed keywords

ANTIPYRETIC AGENT; BIOSIMILAR AGENT; MONOCLONAL ANTIBODY; PF 05280014; TRASTUZUMAB; UNCLASSIFIED DRUG; PF-05280014;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHILL; CONTROLLED STUDY; DEMOGRAPHY; DOUBLE BLIND PROCEDURE; DRUG FEVER; DRUG SAFETY; EUROPEAN UNION; HEADACHE; HUMAN; IMMUNOGENICITY; INFUSION RELATED REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT; CLINICAL TRIAL; COMPARATIVE STUDY;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; AREA UNDER CURVE; DOUBLE-BLIND METHOD; HEALTHY VOLUNTEERS; HUMANS; MALE; MIDDLE AGED; TRASTUZUMAB;

EID: 84919337080     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12464     Document Type: Article

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