Comparative bioavailability study of a generic sustained release diclofenac sodium tablet.
The bioavailability of a generic diclofenac sodium sustained release tablet preparation (Zolterol, SR) was compared with the innovator product, Voltaren, SR. Twelve healthy adult male volunteers participated in the study, which was conducted according to a randomized, two-way crossover design with a wash out period of one week. The bioavailability of diclofenac was compared using the parameters area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax). No statistically significant difference was observed for both logarithmically transformed AUC(0-infinity), Cmax values and Tmax value of the two preparations.
Magosso
E
E
School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.
Yuen
K H
KH
Choy
W P
WP
Ling
S S N
SS
Ng
B H
BH
Ur-Rahman
N
N
Wong
J W
JW
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D013607:Tablets; D004008:Diclofenac