Lionco Pharmaceutical Group Co., Ltd.

Healthy subjects were used as test subjects, esomeprazole magnesium sodium bicarbonate dry suspension (I) (specification: each bag contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1680 mg of sodium bicarbonate) as the test preparation, and esomeprazole sodium bicarbonate capsules (specification: each capsule contains 20 mg of esomeprazole magnesium (calculated as C17H19N3O3S) and 1100 mg of sodium bicarbonate) as the reference preparation. Single and multiple dosing test designs were used to conduct pharmacokinetic and pharmacodynamic comparison tests of the two preparations and the effect of food on the PK parameters of the test preparation: 1. Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple dosing; 2. Compare the pharmacodynamic parameters of the test preparation and the reference preparation after single and multiple dosing; 3. Evaluate the effect of food on the pharmacokinetic parameters of the test preparation; 4. Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main study objectives To study the pharmacokinetics of the test preparation benidipine hydrochloride tablets (specification: 8 mg, produced by Jiangsu Chengkang Pharmaceutical Co., Ltd., provided by Lingkang Pharmaceutical Group Co., Ltd.) and the reference preparation benidipine hydrochloride tablets (Colirol®, specification: 8 mg; certified by Kyowa Kirin Co., Ltd., provided by Lingkang Pharmaceutical Group Co., Ltd.) in healthy adult subjects after single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. Secondary study objectives To study the safety of the test preparation benidipine hydrochloride tablets and the reference preparation benidipine hydrochloride tablets (Colirol®) in healthy adult subjects.

The study was conducted to compare the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the test preparation, acetazolamide sustained-release capsules (Lingkang Pharmaceutical Group Co., Ltd., specification: 500 mg) and the reference preparation, acetazolamide sustained-release capsules (licensed manufacturer: Cadila Healthcare Limited, specification: 500 mg), in healthy subjects after single oral administration on an empty stomach or after meals, to evaluate the bioequivalence of the two preparations in humans, and to observe the safety of the test preparation and the reference preparation in healthy subjects.