Pharmacodynamic properties and bioequivalence of dalteparin sodium subcutaneous injection in healthy Chinese male subjects

Abstract1. Dalteparin sodium (DS) is a low molecular weight heparin that is widely used in the treatment of thromboembolism. The purpose of this study was to compare the pharmacodynamic properties and bioequivalence of the two formulations of DS with subcutaneous injection in healthy Chinese male subjects.2. In this randomized, open-label, two-period crossover study, a total of 24 male subjects were recruited to receive single subcutaneous doses of test and reference DS injection in two different sequences (12 subjects each) with a seven-day washout period. Plasma samples were obtained at different time points after administration of the injection and measured by chromogenic substrate assay. The pharmacodynamic parameters including Emax, AUEC0–T, AUEC0–∞ and Tmax were analyzed to evaluate the bioequivalence of two DS formulations.3. The relative bioequivalence was 107.7 ± 15.5 and 106.6 ± 29.8 for Anti-Xa and Anti-IIa, two major active metabolites of DS, respectively. The 90% confidence intervals (CIs) of...