Absorption of Naproxen Controlled-Release Tablets in Fasting and Postprandial Volunteers

The absorption of naproxen in a new controlled‐release (CR) formulation (1000 mg tablet) was studied in fasting and postprandial volunteers. The total area under the plasma concentration‐time curve averaged 2221 μg · hr/mL in fasting participants and 2111 μg · hr/mL in postprandial participants; whereas the difference was statistically significant (P = .025), the 95% confidence intervals indicated equivalent values. The peak plasma concentration was lower in the fasting state (63.1 μg/mL) than in the fed state (86.1 μg/mL) (P = .0001). There were no statistically significant differences between fasting versus postprandial values for the mean absorption time (9.7 hr vs. 7.7 hr) or plasma half‐life (17.3 hr vs. 17.6 hr). Hence, the rate and extent of absorption of CR naproxen was not substantially altered by the ingestion of food.