Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: An open-label randomised controlled trial

BMC Clinical Pharmacology

Volumn 9, Issue , 2009, Pages

  Sörgel, Fritz ^a   Thyroff Friesinger, Ursula ^b   Vetter, Andrea ^b   Vens Cappell, Bernhard ^c   Kinzig, Martina ^a  

^a IBMP Institute for Biomedical and Pharmaceutical Research   (Germany)

^b Sandoz Biopharmaceuticals   (Germany)

^c Scope International   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BINOCRIT; HEMOGLOBIN; HX 575; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; ANTIANEMIC AGENT; ERYTHROPOIETIN;

ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN EXPERIMENT; INJECTION SITE HYPERSENSITIVITY; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACODYNAMICS; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION; ANEMIA; BLOOD; BLOOD EXAMINATION; COMPARATIVE STUDY; DOSE RESPONSE; ERYTHROCYTE COUNT; INTRAVENOUS DRUG ADMINISTRATION; LEOPARD SYNDROME; METABOLIC CLEARANCE RATE; METABOLISM; PHARMACOKINETICS; TREATMENT OUTCOME;

ADULT; ANEMIA; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME-LINKED IMMUNOSORBENT ASSAY; EPOETIN ALFA; ERYTHROCYTE COUNT; ERYTHROPOIETIN; HEMATINICS; HEMATOLOGIC TESTS; HUMANS; INFUSIONS, INTRAVENOUS; LEOPARD SYNDROME; MALE; METABOLIC CLEARANCE RATE; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 67650067226     PISSN: None     EISSN: 14726904     Source Type: Journal    
DOI: 10.1186/1472-6904-9-10     Document Type: Article

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