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Clinical Drug Investigation

, Volume 25, Issue 11, pp 731–740 | Cite as

Lack of Pharmacokinetic Interaction between Esomeprazole and the Nonsteroidal Anti-Inflammatory Drugs Naproxen and Rofecoxib in Healthy Subjects

  • M. Hassan-Alin
  • J. Naesdal
  • C. Nilsson-Pieschl
  • G. Långström
  • T. Andersson
Original Research Article

Abstract

Background: We investigated the potential interactions between esomeprazole and a non-selective nonsteroidal anti-inflammatory drug (NSAID; naproxen) or a cyclo-oxygenase (COX)-2-selective NSAID (rofecoxib) in healthy subjects.

Methods: Two studies of identical randomised, open, three-way crossover design were conducted. Subjects (n = 32 for both studies) were to receive 1 week’s treatment with esomeprazole 40mg once daily (studies A and B), naproxen 250mg twice daily (study A), rofecoxib 12.5mg once daily (study B), and esomeprazole in combination with naproxen (study A) or rofecoxib (study B). Study periods were separated by a 2-week washout period.

Results: On day 7 of dosing, the ratios (and 95% CIs) for the area under the plasma concentration-time curve during the dosing interval (AUCτ) and observed maximum plasma concentration (Cmax) of esomeprazole and NSAID combination/NSAID alone were 0.98 (0.94, 1.01) and 1.00 (0.97, 1.04), respectively, for study A, and 1.15 (1.06, 1.24) and 1.14 (1.02, 1.28), respectively, for study B. The ratios (and 95% CIs) for AUCτ and Cmax of esomeprazole and NSAID combination/esomeprazole alone were 0.96 (0.89, 1.03) and 0.92 (0.85, 1.00), respectively, for study A, and 1.05 (0.96, 1.15) and 1.05 (0.94, 1.18), respectively, for study B. All treatments were well tolerated during the study period.

Conclusion: Naproxen and rofecoxib do not interact with esomeprazole, and esomeprazole does not affect the pharmacokinetics of naproxen or rofecoxib. These findings indicate that esomeprazole can be used in combination with NSAIDs without the risk of a pharmacokinetic interaction.

Keywords

Celecoxib Naproxen Rofecoxib Esomeprazole Valdecoxib 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The study was sponsored by AstraZeneca R&D Mölndal, Mölndal, Sweden.

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Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  • M. Hassan-Alin
    • 1
  • J. Naesdal
    • 1
  • C. Nilsson-Pieschl
    • 1
  • G. Långström
    • 1
  • T. Andersson
    • 2
  1. 1.Clinical PharmacologyAstraZeneca R&D MölndalMölndalSweden
  2. 2.AstraZeneca LPWilmingtonUSA

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