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法莫替丁与碳酸钙和氢氧化镁固定剂量复方制剂对法莫替丁生物利用度影响的临床研究

Clinical study on the influence of a fixed-dose combination of famotidine with calcium carbonate and magnesium hydroxide on the bioavailability of famotidine.

作者信息

Zhai Qing, Fu Jun, Huang Xia, Xu Bin, Yuan Yao-Zong, Jiang Tao, Rong Zheng-Xing, Chen Hong-Zhuan

机构信息

Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People's Republic of China.

出版信息

Arzneimittelforschung. 2008;58(11):581-4. doi: 10.1055/s-0031-1296560.

DOI:10.1055/s-0031-1296560
PMID:19137909
Abstract

The potential interaction of the H2-receptor antagonist famotidine (CAS 76824-35-6) with calcium carbonate (CAS 471-34-1) and magnesium hydroxide (CAS 1309-42-8) during administration of the famotidine fixed dose combination (FDC) formulation was investigated. A randomized, open-label, two-period, crossover study was carried out on 12 healthy Chinese volunteers. Plasma concentration-time profiles of famotidine were similar with the FDC formulation and common formulation. Confidence interval (90% CI) for maximal concentration (C(max)) and area under the curve (AUC(o-t)) of famoti-dine were 94.8-112.2% and 94.2-112.3%, respectively. These findings suggest that calcium carbonate/magnesium hydroxide antacids have no significant effects on famotidine pharmacokinetics when they are administered together with famotidine as an FDC formulation.

摘要

研究了法莫替丁固定剂量复方制剂(FDC)给药期间,H2受体拮抗剂法莫替丁(CAS 76824-35-6)与碳酸钙(CAS 471-34-1)和氢氧化镁(CAS 1309-42-8)之间的潜在相互作用。对12名健康中国志愿者进行了一项随机、开放标签、两周期交叉研究。法莫替丁FDC制剂和普通制剂的血浆浓度-时间曲线相似。法莫替丁最大浓度(C(max))和曲线下面积(AUC(o-t))的置信区间(90%CI)分别为94.8-112.2%和94.2-112.3%。这些结果表明,碳酸钙/氢氧化镁抗酸剂与法莫替丁以FDC制剂形式一起给药时,对法莫替丁的药代动力学没有显著影响。

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