[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of aluminum magnesium aspirin tablets (II) (Specifications: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, and 11 mg aluminum glycolate) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Lion Corporation为持证商的铝镁匹林片(Ⅱ)(商品名:BUFFERIN Combination Tab. A81,规格:每片含阿司匹林81mg,重质碳酸镁22mg,甘羟铝11mg)为参比制剂,对普济生物科技(台州)有限公司持证,委托乐普制药科技有限公司生产的受试制剂铝镁匹林片(Ⅱ)(规格:每片含阿司匹林81mg,重质碳酸镁22mg,甘羟铝11mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂铝镁匹林片(Ⅱ)(规格:每片含阿司匹林81mg,重质碳酸镁22mg,甘羟铝11mg)和参比制剂铝镁匹林片(Ⅱ)(商品名:BUFFERIN Combination Tab. A81,规格:每片含阿司匹林81mg,重质碳酸镁22mg,甘羟铝11mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, BUFFERIN Combination Tab. A81 (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) with Lion Corporation as the licensee was selected as the reference preparation. The test preparation BUFFERIN Combination Tab. A81 (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) with Puji Biotechnology (Taizhou) Co., Ltd. as the licensee and Lepu Pharmaceutical Technology Co., Ltd. as the production agent was conducted on the fasting and fed human bioequivalence test. The absorption rate and degree of the drug in the test preparation were compared with the reference preparation to see if they were within the acceptable range, and the bioequivalence of the two preparations under fasting and fed conditions was evaluated.
Secondary study objective: To observe the safety of oral administration of the test preparation aluminum magnesium aspirin tablets (II) (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) and the reference preparation aluminum magnesium aspirin tablets (II) (trade name: BUFFERIN Combination Tab. A81, specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) to healthy subjects.