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Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level

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Abstract
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.
Keywords
GENERIC SUBSTITUTION, ANTIEPILEPTIC DRUGS, EPILEPSY

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MLA
Van Lancker, Griet, et al. “Switchability of Gabapentin Formulations : A Randomized Trial to Assess Bioequivalence between Neurontin and Gabasandoz on the Individual Subject Level.” CLINICAL PHARMACOLOGY & THERAPEUTICS, vol. 106, no. 1, 2019, pp. 195–203.
APA
Van Lancker, G., Van Bortel, L., Delafontaine, B., Boussery, K., Swart, E., Chahbouni, A., … Colin, P. (2019). Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level. CLINICAL PHARMACOLOGY & THERAPEUTICS, 106(1), 195–203.
Chicago author-date
Van Lancker, Griet, Lucas Van Bortel, Brant Delafontaine, Koen Boussery, Eleonora Swart, Abdel Chahbouni, Jan Van Bocxlaer, and Pieter Colin. 2019. “Switchability of Gabapentin Formulations : A Randomized Trial to Assess Bioequivalence between Neurontin and Gabasandoz on the Individual Subject Level.” CLINICAL PHARMACOLOGY & THERAPEUTICS 106 (1): 195–203.
Chicago author-date (all authors)
Van Lancker, Griet, Lucas Van Bortel, Brant Delafontaine, Koen Boussery, Eleonora Swart, Abdel Chahbouni, Jan Van Bocxlaer, and Pieter Colin. 2019. “Switchability of Gabapentin Formulations : A Randomized Trial to Assess Bioequivalence between Neurontin and Gabasandoz on the Individual Subject Level.” CLINICAL PHARMACOLOGY & THERAPEUTICS 106 (1): 195–203.
Vancouver
1.
Van Lancker G, Van Bortel L, Delafontaine B, Boussery K, Swart E, Chahbouni A, et al. Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level. CLINICAL PHARMACOLOGY & THERAPEUTICS. 2019;106(1):195–203.
IEEE
[1]
G. Van Lancker et al., “Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level,” CLINICAL PHARMACOLOGY & THERAPEUTICS, vol. 106, no. 1, pp. 195–203, 2019.
@article{8589911,
  abstract     = {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.},
  author       = {Van Lancker, Griet and Van Bortel, Lucas and Delafontaine, Brant and Boussery, Koen and Swart, Eleonora and Chahbouni, Abdel and Van Bocxlaer, Jan and Colin, Pieter},
  issn         = {0009-9236},
  journal      = {CLINICAL PHARMACOLOGY & THERAPEUTICS},
  keywords     = {GENERIC SUBSTITUTION,ANTIEPILEPTIC DRUGS,EPILEPSY},
  language     = {eng},
  number       = {1},
  pages        = {195--203},
  title        = {Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level},
  url          = {http://dx.doi.org/10.1002/cpt.1353},
  volume       = {106},
  year         = {2019},
}

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