SINGLE-DOSE BIOEQUIVALENCE OF CETIRIZINE-PSEUDOEPHEDRINE EXTENDED RELEASE TABLET FORMULATIONS ASSESSED IN HEALTHY SUBJECTS

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Published: 2015-02-28

Page: 1-8


YAHDIANA HARAHAP

Faculty of Pharmacy, University of Indonesia, Indonesia

BUDI PRASAJA *

PT. Clinisindo Laboratories, Jakarta, Indonesia

PRAWITASARI CAHYANINGSIH

PT. Clinisindo Laboratories, Jakarta, Indonesia

WINDY LUSTHOM

PT. Clinisindo Laboratories, Jakarta, Indonesia

VITA FELICIA

PT. Clinisindo Laboratories, Jakarta, Indonesia

LIA YUMI YUSVITA

PT. Clinisindo Laboratories, Jakarta, Indonesia

HARDIYANTI .

PT. Clinisindo Laboratories, Jakarta, Indonesia

*Author to whom correspondence should be addressed.


Abstract

Aim: This study was conducted in order to compare the bioavailability of two extended-release tablets containing 5 mg of cetirizine dihydrochloride and 120 mg of pseudoephedrine hydrochloride.

Methods: Eighteen subjects were enrolled in a single-center, randomized, single-dose, open-label, two-way crossover study with a one-week washout period. Plasma samples were collected up 32 hours following drug administration and both analytes were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with turboionspray mode. Pharmacokinetic parameters used for bioequivalence assessment were AUC0-t, AUC0-∞ and Cmax.

Results: The 90% confidence intervals obtained by analysis of variance for AUC0-t, AUC0-∞ and Cmax were 93.79-106.89%, 93.26-106.37%, 94.14-110.78% for cetirizine and 87.19-108.31%, 87.91-109.51%, 96.34-109.64% for pseudoephedrine, respectively. Both formulations were tolerated and no serious adverse events were reported. These results were all within the range of 80.00-125.00%.

Conclusion: Bioequivalence between formulations was concluded both in terms of rate and extent of absorption.

Keywords: Bioequivalence, cetirizine, pharmacokinetic, pseudoephedrine


How to Cite

HARAHAP, Y., PRASAJA, B., CAHYANINGSIH, P., LUSTHOM, W., FELICIA, V., YUSVITA, L. Y., & ., H. (2015). SINGLE-DOSE BIOEQUIVALENCE OF CETIRIZINE-PSEUDOEPHEDRINE EXTENDED RELEASE TABLET FORMULATIONS ASSESSED IN HEALTHY SUBJECTS. Journal of International Research in Medical and Pharmaceutical Sciences, 3(1), 1–8. Retrieved from https://ikprress.org/index.php/JIRMEPS/article/view/1033

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