A pharmacokinetic comparison of controlled-release and standard naproxen tablets.
The single-dose (750 mg) pharmacokinetics of controlled-release and standard naproxen tablets were compared in a randomized crossover study in 12 healthy male volunteers. Plasma samples collected over the 60 hours after drug administration were assayed for naproxen concentrations using high pressure liquid chromatography. The controlled-release formulation produced a significantly (p less than 0.001) lower and later mean peak naproxen concentration than the conventional-release tablets. However, no differences were observed in either area under the plasma concentration-time curve or elimination half-life. The two formulations were judged, therefore, to be bioequivalent based on the total amount of drug absorbed.
Ryley
N J
NJ
Department of Scientific Affairs, Syntex, Inc., Toronto, Canada.
Lingam
G
G
D000293:Adolescent; D000328:Adult; D003692:Delayed-Action Preparations; D006801:Humans; D009288:Naproxen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011897:Random Allocation; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen