Study of Cetirizine HCl's Absorption and Effects
Author Information
Author(s): Katayoun Derakhshandeh, Mohebbi M.
Primary Institution: Kermanshah University of Medical Sciences
Hypothesis
The study aims to evaluate the pharmacokinetic parameters and bioavailability of cetirizine hydrochloride following a single oral dose.
Conclusion
The two cetirizine products were found to be bioequivalent and could be used interchangeably.
Supporting Evidence
- The pharmacokinetic parameters of cetirizine were determined from plasma concentration-time profiles.
- The study showed no significant differences between the test and reference products.
- The confidence intervals for the pharmacokinetic parameters were within the acceptable range.
Takeaway
The study tested two versions of a medicine called cetirizine to see if they work the same way in the body, and they do!
Methodology
A randomized cross-over study was conducted with 12 healthy volunteers who received a single oral dose of cetirizine, and blood samples were analyzed using HPLC.
Limitations
The study only evaluated a small number of safety parameters.
Participant Demographics
Twelve healthy male volunteers with a mean age of 29 years.
Statistical Information
P-Value
p<0.05
Confidence Interval
90% CI for Cmax: 95-110%, AUC0-24: 91-112%, AUC0-∞: 92-109%
Statistical Significance
p<0.05
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