Anhui Global Pharmaceutical Co., Ltd.

In accordance with the relevant provisions of bioequivalence tests, Procaterol Hydrochloride Tablets (trade name: Meptin-mini, specification: 25μg) produced by OTSUKA PHARMACEUTICAL Co., Ltd was selected as the reference preparation, and the test preparation Procaterol Hydrochloride Tablets (trade name: Kepeng, specification: 25μg) produced by Anhui Global Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test on fasting and postprandial administration to compare whether the differences in the absorption rate and extent of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.

Methods: Using ibuprofen tablets (Motrin IB, 0.2 g/tablet) produced by Johnson and Johnson Consumer Inc McNeil Consumer Healthcare Division as the reference preparation, and ibuprofen tablets (0.2 g/tablet, 1 tablet) produced by Anhui Global Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, two-period, double-crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations in the fasting and fed states.

Irbesartan tablets (specification: 75 mg) produced by Anhui Global Pharmaceutical Co., Ltd. were used as the test preparation, and Irbesartan tablets (trade name: Ambovi, specification 75 mg) produced by Sanofi Clir SNC were 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.