title: Clinical study on the influence of a fixed-dose combination of famotidine with calcium carbonate and magnesium hydroxide on the bioavailability of famotidine.
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.
authors.affiliation: Ruijing Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, The People's Republic of China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Zhai
authors.forename: Jun
authors.initials: J
authors.lastname: Fu
authors.forename: Xia
authors.initials: X
authors.lastname: Huang
authors.forename: Bin
authors.initials: B
authors.lastname: Xu
authors.forename: Yao-Zong
authors.initials: YZ
authors.lastname: Yuan
authors.forename: Tao
authors.initials: T
authors.lastname: Jiang
authors.forename: Zheng-Xing
authors.initials: ZX
authors.lastname: Rong
authors.forename: Hong-Zhuan
authors.initials: HZ
authors.lastname: Chen
mesh_terms: D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002119:Calcium Carbonate / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D015738:Famotidine / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D006633:Histamine Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D006801:Humans; D008276:Magnesium Hydroxide / Q000008:administration & dosage* / Q000494:pharmacology*; D008297:Male; D013607:Tablets
chemical_list: D004338:Drug Combinations; D006633:Histamine Antagonists; D013607:Tablets; D015738:Famotidine; D002119:Calcium Carbonate; D008276:Magnesium Hydroxide