Zhai Qing, Fu Jun, Huang Xia, Xu Bin, Yuan Yao-Zong, Jiang Tao, Rong Zheng-Xing, Chen Hong-Zhuan
Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People's Republic of China.
Arzneimittelforschung. 2008;58(11):581-4. doi: 10.1055/s-0031-1296560.
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.
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。