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Switchability of Gabapentin Formulations: A Randomized Trial to Assess Bioequivalence Between Neurontin and Gabasandoz on the Individual Subject Level
Author(s) -
Van Lancker Griet,
Van Bortel Luc,
Delafontaine Brant,
Boussery Koen,
Swart Eleonora,
Chahbouni Abdel,
Van Bocxlaer Jan,
Colin Pieter
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1353
Subject(s) - bioequivalence , cmax , confidence interval , medicine , crossover study , food and drug administration , pharmacology , randomized controlled trial , gabapentin , bioavailability , mathematics , alternative medicine , pathology , placebo
Generic substitution of antiepileptic drugs is generally not advised by neurologists. The present study investigated the switchability of gabapentin 800 mg tablets (Neurontin and Gabasandoz) using an individual bioequivalence ( IBE ) study design with two batches of each product and assessed whether between‐batch and between‐formulation variability in exposure play a significant role in the within‐subject variability. The trial was analyzed according to the US Food and Drug Administration (FDA) framework to establish IBE . The IBE was shown between both products with the 95% upper confidence bound of the IBE criterion being −2.01 and −2.31 for area under the concentration‐time curve from zero to infinity ( AUC 0–inf ) and peak plasma concentration (C max ), respectively. Subject‐by‐formulation variability (1.35%) was negligible compared with the within‐subject variability of AUC 0–inf with Neurontin (19.0%) and Gabasandoz (23.6%). Inclusion of an additional batch did not significantly change this within‐subject variability (20.2% and 23.6%, respectively). This study shows that substitution of gabapentin 800 mg tablets of Neurontin and Gabasandoz should be possible without affecting clinical outcomes.