Changchun Haiyue Pharmaceutical Co., Ltd

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.

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

Primary objective: Using the certified Aguratimod tablets (trade name: Edexin, 25 mg) of Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation and the Aguratimod tablets produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover clinical study was conducted to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.