Shanxi Deyuantang Pharmaceutical Co. Ltd.

To compare the differences in the extent and rate of absorption of linagliptin tablets (5 mg) provided by Shanxi Deyuantang Pharmaceutical Co., Ltd. and linagliptin tablets (5 mg, trade name: Otangning®/Trajenta®) certified by Boehringer Ingelheim International GmbH in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.

According to the relevant provisions of bioequivalence tests, dapagliflozin tablets (trade name: FORXIGA®, specification: 10 mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10 mg) produced and provided by Shanxi Deyuantang Pharmaceutical Co., Ltd. were subjected to human bioequivalence tests under fasting and postprandial administration conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study objectives: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA®, specification: 10 mg) by healthy volunteers.

Ezetimibe atorvastatin calcium tablets (10 mg/10 mg) produced by Shanxi Deyuantang Pharmaceutical Co., Ltd. was used as the test preparation, and ATOZET® marketed by Merck Sharp & Dohme was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.