A multiple-dose pharmacokinetic comparison of naproxen as a once-daily controlled-release tablet and a twice-daily conventional tablet.
The bioequivalence and absorption kinetics of naproxen in a new controlled-release tablet (750 mg or 1,000 mg naproxen) administered once daily were determined relative to an equivalent dose of the conventional naproxen tablet (375 mg or 500 mg naproxen) administered q12h. Naproxen was well absorbed from the controlled-release tablet (about 90%) compared with the conventional tablet. Absorption was dependent on drug release from the tablet matrix. The mean absorption time of naproxen averaged 8.4 hours for the 750-mg controlled-release tablet and 9.2 hours for the 1,000-mg controlled-release tablet. Once-daily administration of the controlled-release tablet resulted in equivalent trough concentrations of naproxen, and steady-state plasma concentrations were maintained within narrower limits than with twice-daily naproxen.
Ling
T L
TL
Syntex Research, Department of Drug Metabolism, Palo Alto, CA 94304.
Yee
J P
JP
Cohen
A
A
Hsiao
C
C
Gonzalez
M A
MA
Garg
D C
DC
Weidler
D J
DJ
D000328:Adult; D001682:Biological Availability; D003692:Delayed-Action Preparations; D006207:Half-Life; D006801:Humans; D008297:Male; D009288:Naproxen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen