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 micrograms.hr/mL in fasting participants and 2111 micrograms.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 micrograms/mL) than in the fed state (86.1 micrograms/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.