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Esomeprazole 40mg Capsules are Bioequivalent when Administered Intact or as the Contents Mixed with Applesauce

  • Clinical Pharmacokinetics
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Abstract

Objective

This study was conducted to determine whether administration of the contents of an open capsule of esomeprazole (enteric-coated pellets) 40mg with applesauce is bioequivalent to administration of an intact capsule in healthy volunteers.

Participants and Study Design

45 adult male and female volunteers participated in this randomised, single-dose, nonblinded, two-way crossover study conducted at a single centre.

Results

41 volunteers completed the trial. Time to maximum plasma concentration (Cmax) for esomeprazole (tmax) was approximately 2.4 hours and elimination half-life (t1/2) was approximately 0.9 hours by either mode of administration. The ratios of the geometric means for Cmax and area under the plasma concentration-time curve (AUC) for capsule contents with applesauce relative to intact capsule were 0.93 (90% confidence interval [CI]: 0.86 to 1.01) and 0.99 (90% CI: 0.94 to 1.04), respectively. The finding that the 90% CIs were within 0.80 to 1.25 for both parameters indicates bioequivalence. Esomeprazole was well tolerated by the study group irrespective of mode of administration.

Conclusions

Esomeprazole is bioequivalent when administered either as an intact capsule or as the contents of a capsule mixed with applesauce in healthy volunteers. This latter alternative mode of administration may provide benefits to patients who have difficulty swallowing.

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Acknowledgements

The authors express their sincere thanks to Dan Godoy, BS Computer Science, for his proficient data management, and Rebecca A. Kraynak, BS, CCRA, for her overall thorough conduction of the study.

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Authors and Affiliations

  1. Clinical Pharmacology, AstraZeneca LP725, Chesterbrook Blvd, Wayne, Pennsylvania, 19087-5677, USA

    Tommy Andersson, David Magner, Jay Patel, Paul Rogers & Jeffrey G. Levine

Authors
  1. Tommy Andersson
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  2. David Magner
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  3. Jay Patel
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  4. Paul Rogers
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  5. Jeffrey G. Levine
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Corresponding author

Correspondence to Tommy Andersson.

Additional information

A poster of this study was presented at ACG2000.

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Andersson, T., Magner, D., Patel, J. et al. Esomeprazole 40mg Capsules are Bioequivalent when Administered Intact or as the Contents Mixed with Applesauce. Clin. Drug Investig. 21, 67–71 (2001). https://doi.org/10.2165/00044011-200121010-00009

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  • DOI: https://doi.org/10.2165/00044011-200121010-00009

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