/ Not yet recruitingNot Applicable [Translation] Bioequivalence study of aluminum magnesium aspirin tablets (II) in humans
主要试验目的:在健康受试者体内,分别在空腹和餐后条件下,以ライオン株式会社持有的铝镁匹林片(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,河北汇德旭盛医药科技有限公司持有的铝镁匹林片(II)(规格:每片含阿司匹林81mg,重质碳酸镁22mg,甘羟铝11mg;)为受试制剂,研究两制剂的药代动力学,评价两制剂是否具有生物等效性。
次要试验目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study was to study the pharmacokinetics of the two preparations in healthy subjects under fasting and postprandial conditions, using BUFFERIN Combination Tab. A81 (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) held by Lifen Co., Ltd. as the reference preparation and BUFFERIN Combination Tab. A81 (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) held by Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd. as the test preparation, and to evaluate whether the two preparations are bioequivalent.
The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of phloroglucinol orally disintegrating tablets
主要目的:在健康受试者体内,分别在空腹和餐后状态下,以Teva Sante 持有的间苯三酚口崩片(规格:80 mg)为参比制剂,研究河北汇德旭盛医药科技有限公司持有的间苯三酚口崩片(规格:80 mg;受试制剂)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of phloroglucinol orodisintegrating tablets (specification: 80 mg; test preparation) held by Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd. in healthy subjects in fasting and postprandial states, using phloroglucinol orodisintegrating tablets (specification: 80 mg) held by Teva Sante as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence Study of Enteric-coated Aspirin Tablets
主要目的:在健康受试者体内,在空腹和餐后条件下,以Bayer S.p.A 持有的阿司匹林肠溶片(规格:100 mg)为参比制剂,河北汇德旭盛医药科技有限公司持有的阿司匹林肠溶片(规格:100 mg;受试制剂)为受试制剂,研究两制剂的药代动力学,评价两制剂是否具有生物等效。 次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of enteric-coated aspirin tablets (specification: 100 mg) held by Bayer S.p.A. as the reference preparation and enteric-coated aspirin tablets (specification: 100 mg; test preparation) held by Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd. as the test preparation in healthy subjects under fasting and postprandial conditions, and to evaluate whether the two preparations are bioequivalent. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd
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100 Deals associated with Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Hebei Huide Xusheng Pharmaceutical Technology Co., Ltd