A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects

Clinical Therapeutics

Volumn 38, Issue 7, 2016, Pages 1665-1673.e3

  Pivot, Xavier ^a   Curtit, Elsa ^a   Lee, Yoon Jung ^b   Golor, George ^c   Gauliard, Anke ^c   Shin, Donghoon ^b   Kim, Youngdoe ^b   Kim, Hansook ^b   Fuhr, Rainard ^c  

^a UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^b Samsung Bioepis Co Ltd   (South Korea)

^c PAREXEL INTERNATIONAL   (United States)

Author keywords

biosimilars; breast cancer; Herceptin ; pharmacokinetic equivalence; trastuzumab

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; NEUTRALIZING ANTIBODY; PARACETAMOL; SB 3; TRASTUZUMAB; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CONTROLLED STUDY; DEMOGRAPHY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; FATIGUE; FEVER; HEADACHE; HUMAN; HYPERHIDROSIS; IMMUNOGENICITY; INFUSION RELATED REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCLE SPASM; NORMAL HUMAN; PALLOR; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; BIOTINYLATION; CHEMISTRY; CLINICAL TRIAL; COMPARATIVE STUDY; MIDDLE AGED;

ADULT; ANTINEOPLASTIC AGENTS; BIOSIMILAR PHARMACEUTICALS; BIOTINYLATION; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; TRASTUZUMAB;

EID: 84977646077     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2016.06.002     Document Type: Article

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