[Translation] A single oral fasting, open-label, dose-finding trial of acarbose tablets in healthy Chinese subjects
主要研究目的:1)以血浆中葡萄糖浓度为药效动力学评价指标,探索中国健康受试者空腹口服拜耳医药保健有限公司阿卡波糖片后产生药效学反应的最佳剂量,确定正式生物等效性试验的适宜给药剂量;2)根据试验结果对比不同药效动力学参数处理方法差异,为正式试验探索合适的等效性评价指标。
次要研究目的:研究不同剂量阿卡波糖片(50 mg、100 mg和150 mg)在中国健康受试者中的安全性。
[Translation] The main research objectives: 1) Using plasma glucose concentration as the pharmacodynamic evaluation index, explore the optimal dose of acarbose tablets produced by Bayer Healthcare Co., Ltd. in healthy Chinese subjects after fasting oral administration to produce pharmacodynamic response, and determine the appropriate dosage for formal bioequivalence trials; 2) Compare the differences in the treatment methods of different pharmacodynamic parameters based on the test results, and explore appropriate equivalence evaluation indicators for formal trials.
Secondary research objectives: To study the safety of different doses of acarbose tablets (50 mg, 100 mg and 150 mg) in healthy Chinese subjects.