UGC Approved Journal no 63975(19)

ISSN: 2349-5162 | ESTD Year : 2014
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Published in:

Volume 7 Issue 6
June-2020
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR2006565


Registration ID:
234720

Page Number

1594-1606

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Title

BIOEQUIVALENCE STUDY OF CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLET IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION

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: Fourty 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 (LCMS/ 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%, 94.14-112.44% for cetirizine and 87.19-108.31%, 87.91-109.51%, 96.34-112.64% 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.

Key Words

Bioequivalence; cetirizine; pharmacokinetic; pseudoephedrine

Cite This Article

"BIOEQUIVALENCE STUDY OF CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLET IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.7, Issue 6, page no.1594-1606, June 2020, Available :http://www.jetir.org/papers/JETIR2006565.pdf

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2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"BIOEQUIVALENCE STUDY OF CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLET IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.7, Issue 6, page no. pp1594-1606, June 2020, Available at : http://www.jetir.org/papers/JETIR2006565.pdf

Publication Details

Published Paper ID: JETIR2006565
Registration ID: 234720
Published In: Volume 7 | Issue 6 | Year June-2020
DOI (Digital Object Identifier):
Page No: 1594-1606
Country: Pune, Maharashtra, India .
Area: Pharmacy
ISSN Number: 2349-5162
Publisher: IJ Publication


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