Comparative bioavailability of two cetirizine tablet formulations in Indonesian healthy volunteers.
OBJECTIVE
To compare the bioavailability of two cetirizine tablet (10 mg) formulations (ZyrtecA from UCB Pharma, Spain as a reference formulation and RyvelA from Novell Pharmaceutical Laboratories, Indonesia as a test formulation).


METHODS
The study was conducted according to an open, randomized, two-period crossover design with a 1-week washout period. Eighteen volunteers participated and all completed the study successfully. Blood samples were obtained prior to dosing and at 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 and 30 hours after drug administration. Plasma concentrations of cetirizine were monitored using high-performance liquid chromatography over a period of 30 hours after administration. The pharmacokinetics parameter AUC(0-30h), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data and ratios of t(max) were evaluated non-parametrically.


RESULTS
The point estimates and 90% confidence intervals for AUC(0-30h), AUC(0-infinity) and C(max) were 108.23% (101.90 â 114.95%), 108.11% (101.91 â 114.68%) and 99.71% (90.18 â 110.25%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products an the US Food and Drug Administration guidelines.


CONCLUSIONS
These results indicate that two medications of cetirizine are bioequivalent and, thus, may be prescribed interchangeably.
Department of Pharmacy, Faculty of Mathematics and Science, University of Indonesia, Depok, Indonesia. yahdiana03@yahoo.com
Y
Y
Harahap
B
B
Prasaja
E
E
Indriati
W
W
Lusthom
Lipin
D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D017332:Cetirizine / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D007214:Indonesia; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D039563:Histamine H1 Antagonists, Non-Sedating; D013607:Tablets; D017332:Cetirizine