Changchun Haiyue Pharmaceutical Co., Ltd

The main purpose of the study was to use Epinastine Hydrochloride Tablets produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation and Epinastine Hydrochloride Tablets (trade name: Alesion, 20 mg) certified by Nippon Boehringer Ingelheim Co., Ltd. as the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions through a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover clinical study. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

The main purpose of the study is to use the naproxen sodium tablets (trade name: Apranax®, specification: 275 mg) certified by Atnahs Pharma Netherlands B.V. as the reference preparation and the naproxen sodium tablets (specification: 0.275 g (equivalent to naproxen 250 mg)) produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-period, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

This study aimed to study the pharmacokinetic characteristics of compound bismuth potassium subcitrate capsules (bismuth potassium subcitrate 140 mg/metronidazole 125 mg/tetracycline hydrochloride 125 mg) developed and produced by Changchun Haiyue Pharmaceutical Co., Ltd. after a single oral administration after meal; compound bismuth potassium citrate capsules (PYLERA®, bismuth potassium subcitrate 140 mg/metronidazole 125 mg/tetracycline hydrochloride 125 mg) produced by Allergan USA.Inc. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.