HARAHAP, YAHDIANA and PRASAJA, BUDI and CAHYANINGSIH, PRAWITASARI and LUSTHOM, WINDY and FELICIA, VITA and YUSVITA, LIA YUMI and ., HARDIYANTI (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). pp. 1-8.
Full text not available from this repository.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.
| Item Type: | Article |
|---|---|
| Subjects: | Library Keep > Medical Science |
| Depositing User: | Unnamed user with email support@librarykeep.com |
| Date Deposited: | 06 Jan 2024 03:30 |
| Last Modified: | 06 Jan 2024 03:30 |
| URI: | http://archive.jibiology.com/id/eprint/2062 |
Actions (login required)
- View Item