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Drug Design, Development and Therapy
Article . 2012 . Peer-reviewed
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Drug Design, Development and Therapy
Article
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PubMed Central
Article . 2012
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Dove Medical Press
Article . 2012 . Peer-reviewed
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Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects

Authors: Tjandrawinata,Raymond R; Setiawati,Effi; Yunaidi,Danang Agung; Santoso,Iwan Dwi; Setiawati,Arini; Susanto,Liana W;

Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects

Abstract

The present study was conducted to compare the bioavailability of two bisoprolol fumarate 5 mg film-coated tablet formulations (test and reference formulations).This study was a randomized, single-blind, two-period, two-sequence crossover study that included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were determined based on the concentrations of bisoprolol (CAS 66722-44-9), using ultraperformance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout of 1 week) a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration-time curve from time zero to 48 hours (AUC(t)), AUC from time zero to infinity (AUC(inf)), the peak plasma concentration of the drug (C(max)), time needed to achieve C(max) (t(max)), and the elimination half-life (t(1/2)).The geometric mean ratios (90% confidence intervals) of the test drug/reference drug for bisoprolol were 101.61% (96.14%-107.38%) for AUC(t), 101.31% (95.66%-107.29%) for AUC(inf), and 100.28% (93.90%-107.09%) for C(max). The differences between the test and reference drug products for bisoprolol t(max) and t(1/2) values were not statistically significant (P > 0.05). There was no adverse event encountered during this bioequivalence test. The 90% confidence intervals of the test/reference AUC ratio and C(max) ratio of bisoprolol were within the acceptance range for bioequivalence.It was concluded that the two bisoprolol film-coated tablet formulations (the test and reference products) were bioequivalent in terms of the rate and extent of absorption.

Keywords

Adult, Male, Drug Design, Development and Therapy, Cross-Over Studies, Chemistry, Pharmaceutical, RM1-950, Adrenergic beta-1 Receptor Antagonists, Therapeutic Equivalency, Area Under Curve, Bisoprolol, Humans, Female, Single-Blind Method, Therapeutics. Pharmacology, Original Research, Tablets

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    13
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
13
Top 10%
Top 10%
Average
Green
gold