A Phase I Dose-Escalation and Bioequivalence Study of a Trastuzumab Biosimilar in Healthy Male Volunteers

Clinical Drug Investigation

Volumn 34, Issue 12, 2014, Pages 887-894

  Wisman, Liselijn A B ^a   De Cock, Eduard P M ^a   Reijers, Joannes A A ^b   Kamerling, Ingrid M C ^b   Van Os, Sandra H G ^a   de Kam, Marieke L ^b   Burggraaf, Jacobus ^b   Voortman, Gerrit ^a  

^a SYNTHON BV   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; PLACEBO; TRASTUZUMAB; MONOCLONAL ANTIBODY;

ACNE; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CARDIOTOXICITY; CHILL; CONJUNCTIVITIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEVER; FLATULENCE; FLU LIKE SYNDROME; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; MYALGIA; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COHORT ANALYSIS; CROSSOVER PROCEDURE; DOSE RESPONSE; SINGLE BLIND PROCEDURE; THERAPEUTIC EQUIVALENCE; YOUNG ADULT;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOSIMILAR PHARMACEUTICALS; COHORT STUDIES; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HEADACHE; HEALTHY VOLUNTEERS; HUMANS; MALE; SINGLE-BLIND METHOD; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84911972652     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-014-0247-5     Document Type: Article

References (14)

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