Zibo Wanjie Pharmaceutical Co. Ltd.

Telmisartan tablets (specification: 80 mg/tablet; trade name: Micardis®) produced by the original research company Boehringer Ingelheim International GmbH were used as the reference preparation, and Telmisartan tablets (specification: 80 mg/tablet) produced by Zibo Wanjie Pharmaceutical Co., Ltd. were used as the test preparation. A single-center, randomized, open, single-dose, two-preparation, three-period, three-sequence, partially repeated, reference preparation-corrected clinical study was conducted to evaluate the bioequivalence of the two preparations in humans under fasting and fed conditions.

Telmisartan tablets provided by Zibo Wanjie Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence study, the absorption rate and degree of Telmisartan tablets (trade name: Micardis®, reference preparation) produced by Boehringer Ingelheim Pharma GmbH & Co.KG (licensed manufacturer: Boehringer Ingelheim International GmbH) were compared in healthy humans to investigate the bioequivalence of the two preparations in humans.

Main purpose: Using glipizide controlled-release tablets (Reiyi Ning®, 5 mg/tablet) produced by Pfizer Pharmaceuticals LLC as the reference preparation and glipizide controlled-release tablets (5 mg/tablet) produced by Zibo Wanjie Pharmaceutical Co., Ltd. as the test preparation, the pharmacokinetic characteristics of the two preparations were preliminarily compared through a randomized, open, two-formulation, single-dose, double-period, double-crossover trial design, and the bioequivalence of the two preparations under fasting and postprandial administration conditions was preliminarily evaluated. Secondary purpose: Preliminary evaluation of the safety of the test and reference preparations of glipizide controlled-release tablets after a single oral administration on an empty stomach and after a meal in healthy Chinese subjects.