[Translation] A single-center, single-dose, fasting/postprandial, 2-preparation, 2-cycle, 2-sequence, open-label, randomized, crossover bioequivalence trial of pioglitazone and metformin tablets was conducted in healthy subjects.
在健康受试者体内,分别在空腹、餐后状态下,以武田テバ薬品株式会社持有的吡格列酮二甲双胍片(规格:每片含盐酸吡格列酮15 mg(以吡格列酮计)和盐酸二甲双胍500 mg)为参比制剂,研究北京福元医药股份有限公司研制的吡格列酮二甲双胍片(受试制剂;规格:每片含盐酸吡格列酮15 mg(以吡格列酮计)和盐酸二甲双胍500 mg)的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] In healthy subjects, pioglitazone hydrochloride and metformin tablets (specifications: each tablet contains 15 mg of pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg of metformin hydrochloride) held by Takeda Tubo Co., Ltd. were tested in the fasting and postprandial states. As a reference preparation, the absorption rate and degree of absorption of pioglitazone and metformin tablets (test preparation; specifications: each tablet contains 15 mg of pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg of metformin hydrochloride) developed by Beijing Fuyuan Pharmaceutical Co., Ltd. were evaluated. Whether the test preparation and the reference preparation are bioequivalent. Observe the safety of the test preparation and reference preparation in Chinese healthy subjects.