[Translation] Pharmacodynamic Bioequivalence Clinical Trial of Nadroparin Calcium
1. 研究中国健康男性受试者交叉、单次、皮下注射国产注射用那屈肝素钙和原研药品那屈肝素钙注射液的药效动力学,评价二制剂间是否存在生物等效性。 2. 研究那屈肝素钙的药代动力学(抗Ⅹa因子活性PK,抗Ⅱa因子活性PK)。
[Translation] 1. To study the pharmacodynamics of crossover, single, subcutaneous injection of domestic nadroparin calcium for injection and original research drug nadroparin calcium injection in Chinese healthy male subjects, and to evaluate whether there is bioequivalence between the two preparations. 2. To study the pharmacokinetics of nadroparin calcium (anti-factor Xa activity PK, anti-Ⅱa factor activity PK).
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