Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers

Cho, H Y; Kang, Hyunah; Lee, Y B

doi:10.5414/cpp44386

Cited by 5 publications

(2 citation statements)

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“…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%

“…The HPLC-UV is a sensitive method with excellent sensitivity and reproducibility for application in bioequivalence studies of gabapentin,25,26 as was also demonstrated in our own validation data. Other former bioequivalence studies with different gabapentin formulations conducted by Wittayalertpanya et al,21 Cho et al22 and Almeida et al23 also used the HPLC method, but with fluorescence21,22 or mass spectrometry (MS) detector,23 instead of UV detector as used in our study. In this study, UV detector was preferred to fluorescence or to MS detector because the level of gabapentin in human plasma is sufficient for detection by UV detector.…”

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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“…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%

Section: Discussionmentioning

confidence: 99%

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

Tjandrawinata¹,

Setiawati

Putri

et al. 2014

DDDT

View full text Add to dashboard Cite

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The Effect ofMDR1 G2677T/A polymorphism on pharmacokinetics of gabapentin in healthy Korean subjects

2007

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This study evaluated the relationship between the genetic polymorphism in the MDR1 (exon 21) genes and the pharmacokinetics of gabapentin (GBP) in healthy Korean subjects. The healthy Koreans were genotyped with respect to MDR1 (exon 21, 30 subjects) using polymerase chain reaction-based diagnostic testing. The pharmacokinetic profile of GBP was examined. A single oral dose of 300 mg GBP in a capsule was administered to the subjects and the blood samples were taken during a 24 h post-dose interval. The serum GBP concentration was measured using an HPLC-fluorescence detector system. There were no significant (P < 0.05) differences between the genotypes and pharmacokinetic parameters such as AUC(0-1h), AUC(0-1.5h), AUC(0-infinity), Cmax and t1/2. However, there was a trend toward higher values of the absorptive phase characterized by the AUC(0-1h) and AUC(0-1.5h) in 2677T/A subjects. In conclusion, this study suggests that GBP may be a weak substrate for the P-glycoprotein (P-gp) transporter.

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Meta-analyses of dose-exposure relationships for gabapentin following oral administration of gabapentin and gabapentin enacarbil

Chen

2013

Eur J Clin Pharmacol

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Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers

Cited by 5 publications

References 0 publications

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

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

The Effect ofMDR1 G2677T/A polymorphism on pharmacokinetics of gabapentin in healthy Korean subjects

Meta-analyses of dose-exposure relationships for gabapentin following oral administration of gabapentin and gabapentin enacarbil

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