Interchangeability of Gabapentin Generic Formulations in the Netherlands: A Comparative Bioavailability Study

Yu, Yang; Teerenstra, Steven; Vanmolkot, Floris; Neef, Cees; Burger, David M.; Maliepaard, Marc

doi:10.1038/clpt.2013.108

Cited by 23 publications

(42 citation statements)

References 25 publications

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“…The test preparation of gabapentin evaluated in this study was of a different formulation and manufacturer than those evaluated in previous similar publications of gabapentin bioequivalence 21–24. Moreover, our study evaluated the bioavailability of a lower dose of gabapentin preparation (300 mg capsule) than those in former similar studies (400 mg to 800 mg capsules) 22–24…”

Section: Discussionmentioning

confidence: 99%

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Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects

Tjandrawinata¹,

Setiawati

Putri

et al. 2014

DDDT

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BackgroundThe current study was conducted to find out whether two oral preparations of 300 mg gabapentin (the test and reference capsules) were bioequivalent.Subjects and methodsThis was a randomized, single-blind, crossover study under fasting condition, with a 7-day washout period, which included 37 healthy adult male and female subjects. After an overnight fast, subjects were given, orally, one capsule of the test drug or of the reference drug. Blood samples were drawn immediately before taking the drug, then at 20 and 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, and 24 hours after dosing, to evaluate pharmacokinetic parameters of the single dose administration, ie, the area under the plasma concentration–time curve (AUC) from time zero to 24 hours (AUCt), AUC from time zero to infinity (AUCinf), the peak plasma concentration of the drug (Cmax), time needed to achieve Cmax (tmax), and the elimination half-life (t1/2). The plasma concentrations of gabapentin were determined using validated high-performance liquid chromatography with ultraviolet detection.ResultsThe geometric mean ratios (90% confidence interval) of the test drug/reference drug for gabapentin were 103.15% (90.38%–117.72%) for AUCt, 103.53% (90.78%–118.07%) for AUCinf, and 108.06% (96.32%–121.24%) for Cmax. The differences in tmax and t1/2 values between the test and reference drug products for gabapentin were not statistically significant. Light-headedness, nausea, and headache were encountered during the study, but they were all mild and well tolerated. The 90% confidence intervals of the test/reference AUC ratio and Cmax ratio of gabapentin were within the acceptance range for bioequivalence.ConclusionThe two preparations of gabapentin 300 mg capsule were bioequivalent, thus both can be used interchangeably in the clinical setting.

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Section: Discussionmentioning

confidence: 99%

“…Moreover, our study evaluated the bioavailability of a lower dose of gabapentin preparation (300 mg capsule) than those in former similar studies (400 mg to 800 mg capsules) 22–24…”

Section: Discussionmentioning

confidence: 99%

Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects

Tjandrawinata¹,

Setiawati

Putri

et al. 2014

DDDT

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“…6 Whereas the findings are reassuring, prudence dictates that changing the brand of a prescription (whether original or generic) is justified only if there is a good reason for it. This is because medications contain a number of excipients; since these excipients will certainly vary from generic to generic, the safety profile of a generic may change as a function of the contained excipients.…”

Section: Parting Notesmentioning

confidence: 99%

Bioequivalence of Generic Drugs

Andrade¹

2015

J. Clin. Psychiatry

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“…Methods: Data was gathered in a 4-way crossover study in 24 subjects with 4 different oral formulations of gabapentin previously concluded to be bioequivalent by non-compartmental analysis. 1 The non-parametric pharmacokinetic modelling software Pmetrics was used, which is capable of identifying unprespecified subpopulations in pharmacokinetic data. 2 Models were validated using visual predictive checks (VPCs) and the Akaike information criterion (AIC).…”

Section: Discussionmentioning

confidence: 99%