Shanxi Ante Bio-Pharmaceutical Co., Ltd.

In healthy subjects, the pharmacokinetics of trimebutine maleate tablets (specification: 100 mg; test preparation) developed by Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd. were studied under fasting and postprandial conditions, using trimebutine maleate tablets (trade name: Cerekinon®; specification: 100 mg) owned by Mitsubishi Tanabe Pharma Corporation as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. Secondary study objective: To observe the safety of oral administration of the test preparation and the reference preparation in healthy subjects.

The efficacy and safety of quadruple therapy containing colloidal bismuth pectin capsules in eradicating Hp were evaluated by using quadruple therapy containing potassium citrate bismuth tablets as a control.

Two specifications of colloidal pectin bismuth capsules developed and produced by Shanxi Zhendong Ante Biopharmaceutical Co., Ltd. were used as the test preparations, and potassium citrate bismuth tablets produced by Industria Química y Farmacéutica VIR, S.A. (licensed manufacturer: Tora Laboratories S.L.) was used as the reference preparation. The absorption extent of the three in the plasma of healthy Chinese volunteers was compared. The renal clearance and excretion fraction of bismuth in urine and feces were evaluated to assess their material balance.