[Translation] An open-label, randomized, single-dose, three-period, three-sequence, semi-repeated crossover trial of minodronic acid tablets in fasting
以中国健康受试者为对象,研究辅仁药业集团有限公司生产的米诺膦酸片(受试制剂,规格:1 mg/片)与小野药品工业株式会社生产的米诺膦酸片(参比制剂,Recalbon,规格:1 mg/片)的药代动力学特征,评价空腹条件下单次服药(1 mg)的人体生物等效性。
[Translation] Methods: The pharmacokinetic characteristics of minodronic acid tablets (test preparation, strength: 1 mg/tablet) produced by Furen Pharmaceutical Group Co., Ltd. and minodronic acid tablets (reference preparation, Recalbon, strength: 1 mg/tablet) produced by Ono Pharmaceutical Co., Ltd. were studied in healthy Chinese subjects, and the bioequivalence of a single dose (1 mg) under fasting conditions was evaluated.