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

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

Tjandrawinata RR - Personal Name;

The 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

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Gapenal-003

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Language: English
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Subject(s): Gapenal
Gabapentin
Specific Detail Info: Drug Design, Development and Therapy 2014:8 1249–1255
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