[Translation] A randomized, open-label, two-sequence, two-period crossover bioequivalence study of acarbose tablets in Chinese healthy volunteers after single oral administration
主要目的: 研究单次口服阿卡波糖片受试制剂(50mg/片,南京白敬宇制药有限责任公司生产)与阿卡波糖片参比制剂(PRECOSE®50 mg/片,德国 Bayer Pharma AG 生产)在中国健康志愿者体内的药效动力学,评价阿卡波糖片受试制剂与参比制剂是否具有生物等效性。 次要目的:评估中国健康志愿者单次口服阿卡波糖片的安全性。
[Translation] Primary objective: To study the pharmacodynamics of acarbose tablets (50 mg/tablet, produced by Nanjing Baijingyu Pharmaceutical Co., Ltd.) and acarbose tablets reference formulation (PRECOSE® 50 mg/tablet, produced by Bayer Pharma AG, Germany) in healthy Chinese volunteers, and to evaluate whether the acarbose tablets test formulation and the reference formulation are bioequivalent. Secondary objective: To evaluate the safety of acarbose tablets in healthy Chinese volunteers after a single oral administration.