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_0–t) of famotidine 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.

Key words

Antacids - Calcium carbonate, fixed dose combination, interaction with famotidine - CAS 76824-35-6 - Famotidine, bioavailability, fixed dose combination, pharmacokinetics - Histamine H₂-receptor antagonists - Magnesium hydroxide, fixed dose combination, interaction with famotidine

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