Bioequivalence of generic and branded subcutaneous enoxaparin: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Chinese male subjects

Clinical Therapeutics

Volumn 31, Issue 7, 2009, Pages 1559-1567

  Feng, Limin ^a   Shen Tu, Jianzhong ^b   Liu, Jian ^b   Chen, Junchun ^b   Wu, Lihua ^b   Huang, Mingzhu ^b  

^a First Affiliated Hospital   (China)

^b ZHEJIANG UNIVERSITY   (China)

Author keywords

anti IIa activity; anti Xa activity; aPTT; bioequivalence; enoxaparin; heparin clotting assay

Indexed keywords

BLOOD CLOTTING FACTOR 10A; ENOXAPARIN; GENERIC DRUG; PROTHROMBIN;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG ELIMINATION; DRUG FORMULATION; DRUG TOLERABILITY; HALF LIFE TIME; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANTICOAGULANTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BLOOD COAGULATION TESTS; CHINA; CROSS-OVER STUDIES; DRUGS, GENERIC; ENOXAPARIN; FACTOR XA; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 68949125306     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.07.017     Document Type: Article

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