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Pharmacokinetics and Relative Bioavailability of a Fixed‐Dose Combination of Enteric‐Coated Naproxen and Non‐Enteric‐Coated Esomeprazole Magnesium
Author(s) -
WangSmith Laurene,
Fort John,
Zhang Ying,
Sostek Mark
Publication year - 2012
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270011405500
Subject(s) - esomeprazole , naproxen , bioequivalence , bioavailability , nap , pharmacokinetics , crossover study , pharmacology , medicine , enteric coating , dosage form , placebo , alternative medicine , pathology , neuroscience , biology
This randomized, 4‐way crossover study assessed the single‐dose pharmacokinetics and relative bioavailability of naproxen and esomeprazole after administration of a fixed‐dose combination tablet of enteric‐coated (EC) naproxen 500 mg and non‐EC esomeprazole magnesium 20 mg (NAP/ESO tablet). Equivalent doses of an EC naproxen tablet plus an EC esomeprazole magnesium capsule taken concomitantly, an EC naproxen tablet alone, or an EC esomeprazole magnesium capsule alone were used as comparators. Forty healthy adults were randomized to receive 4 study treatments with a washout interval ≥12 days. Naproxen plasma profiles were similar between the NAP/ESO tablet and EC naproxen, although median t max was longest for the NAP/ESO tablet (5.3 vs 3.5–4.0 hours). Naproxen C max , AUC 0‐∞ , and AUC 0‐t showed bioequivalence between naproxen formulations. The NAP/ESO tablet produced much shorter esomeprazole t max than the EC esomeprazole formulation (0.45 vs 2.5 hours). Esomeprazole C max and AUCs were comparable between the EC esomeprazole formulation administered with or without EC naproxen but were lower with the NAP/ESO tablet. In conclusion, there are no pharmacokinetic drug interactions between naproxen and esomeprazole. The NAP/ESO tablet is bioequivalent to EC naproxen, and as expected, the bioavailability of non‐EC esomeprazole from the NAP/ESO tablet is lower than the EC esomeprazole formulation.