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

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

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Area Under Curve
  • Biological Availability
  • Calcium Carbonate / administration & dosage*
  • Calcium Carbonate / pharmacokinetics*
  • Calcium Carbonate / pharmacology*
  • Chemistry, Pharmaceutical
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Combinations
  • Famotidine / administration & dosage*
  • Famotidine / pharmacokinetics*
  • Female
  • Histamine Antagonists / administration & dosage*
  • Histamine Antagonists / pharmacokinetics*
  • Humans
  • Magnesium Hydroxide / administration & dosage*
  • Magnesium Hydroxide / pharmacology*
  • Male
  • Tablets

Substances

  • Drug Combinations
  • Histamine Antagonists
  • Tablets
  • Famotidine
  • Calcium Carbonate
  • Magnesium Hydroxide