Comparative bioavailability of two cetirizine tablet formulations in Indonesian healthy volunteers.
Int J Clin Pharmacol Ther
; 46(5): 268-72, 2008 May.
Article
in En
| MEDLINE
| ID: mdl-18538113
ABSTRACT
AIM:
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). MATERIAL ANDMETHODS:
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.RESULT:
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.CONCLUSION:
These results indicate that two medications of cetirizine are bioequivalent and, thus, may be prescribed interchangeably.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cetirizine
/
Histamine H1 Antagonists, Non-Sedating
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Adolescent
/
Adult
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
En
Journal:
Int J Clin Pharmacol Ther
Journal subject:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2008
Type:
Article
Affiliation country:
Indonesia