Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: An open-label, randomized-sequence, three-treatment, three-way crossover study

Clinical Therapeutics

Volumn 31, Issue 5, 2009, Pages 1046-1053

  Cho, Sang Heon ^a   Lim, Hyeong Seok ^a   Ghim, Jong Lyul ^a   Choe, Sangmin ^a   Kim, Un Jib ^a   Jung, Jin Ah ^a   Bae, Kyun Seop ^a  

^a University of Ulsan College of Medicine   (South Korea)

Author keywords

albumin free formulation; bioequivalence; erythropoietin; pharmacokinetics; tolerability

Indexed keywords

AROPOTIN; ESPOGEN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CROSSOVER PROCEDURE; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; GASTROINTESTINAL SYMPTOM; HALF LIFE TIME; HEMATURIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN EXPERIMENT; LACTATE DEHYDROGENASE BLOOD LEVEL; LEG PAIN; LEUKOCYTURIA; LOW BACK PAIN; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SINGLE DRUG DOSE; SOUTH KOREA; SWELLING; TIME TO MAXIMUM PLASMA CONCENTRATION; WEAKNESS;

ADULT; AREA UNDER CURVE; BILIRUBIN; CREATINE KINASE; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; ERYTHROPOIETIN, RECOMBINANT; FOLLOW-UP STUDIES; HEMATINICS; HUMANS; IMMUNOENZYME TECHNIQUES; L-LACTATE DEHYDROGENASE; MALE; MIDDLE AGED; REFERENCE VALUES; THERAPEUTIC EQUIVALENCY;

EID: 66949138584     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.05.013     Document Type: Article

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