Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablet Compared to Famotidine/Antacid EZ Chew Tablet

Abstract

Purpose: Famotidine/antacid combination tablets (FACT) combine 10 mg of a potent H2 receptor antagonist with standard Ca and Mg containing antacids. This combination has been shown to have the benefit of more rapid relief of symptoms than famotidine alone, and a longer duration of relief than antacid alone. While extremely effective for relieving heartburn, the chewable tablet of the original formulation has been described as gritty with an unappealing mouth feel. To provide an alternative formulation for consumers, a softer, smoother, and non-gritty tablet or an “EZ Chew” formulation of FACT has been developed. In a separate taste test, strong preference is shown for the new EZ Chew tablets over the original formulation of FACT. Methods: Twenty-four healthy subjects underwent a prestudy visit and 3 treatment sessions with each session separated by ˜1 week. Subjects were randomly assigned to 1 of 6 treatment sequences and received each of the 3 treatments in a randomized order. The 3 treatments included FACT with water, EZ Chew with water, and EZ Chew without water. Following an overnight fast, subjects received the designated treatment and blood was collected over 24 hours postdose for measurement of famotidine concentrations at specified times following each treatment. Results: The study demonstrated that a single dose of EZ Chew without water is bioequivalent to a single dose of FACT, as the 90% confidence interval for the geometric mean ratios (EZ/FACT) for AUC0-∞ and Cmax both fall within the prespecified bounds of (0.80, 1.25). The AUC0-∞ and Cmax geometric mean ratios for FACT and EZ Chew without water were 1.05 and 1.03, respectively, and the 90% confidence intervals were (0.98, 1.13) and (0.93, 1.13). The median Tmax was 1.25 and 1.75 hours, and the median apparent half-life was 4.60 and 4.56 hours, respectively. The study also demonstrated similar bioequivalence for EZ Chew with water. Conclusion: EZ Chew tablet taken both with and without water and FACT are bioequivalent for famotidine with respect to AUC0-∞ and Cmax. (The study did not assess the bioequivalence of antacid component.) The improved mouth feel and consumer taste preference should make the new EZ Chew product more palatable to consumers. Disclosure: Amy Replogle - Employee: Merck & Co., Inc. Peggy Hwang - Employee: Merck & Co., Inc. Robert Blum - Investigator - Buffalo Clinical Research Center. Jeff Levine - Employee: Merck & Co., Inc.