Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study

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Title:	Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study
Author(s):	Yu, Y.; Teerenstra, S. ; Vanmolkot, F.; Neef, C.; Burger, D.M. ; Maliepaard, M.
Publication year:	2013
Source:	Clinical Pharmacology and Therapeutics, vol. 94, iss. 4, (2013), pp. 519-524
ISSN:	0009-9236
DOI:	https://doi.org/10.1038/clpt.2013.108
Publication type:	Article / Letter to editor
Please use this identifier to cite or link to this item : https://hdl.handle.net/2066/119121
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Subject:	N4i 3: Poverty-related infectious diseases NCEBP 13: Infectious diseases and international health NCEBP 2: Evaluation of complex medical interventions NCEBP 6: Quality of nursing and allied health care NCMLS 5: Membrane transport and intracellular motility IGMD 9: Renal disorder NCEBP 6: Quality of nursing and allied health care
Organization:	Health Evidence IQ Healthcare Clinical Pharmacy Pharmacology-Toxicology
Former Organization:	Epidemiology, Biostatistics & HTA
Journal title:	Clinical Pharmacology and Therapeutics
Volume:	vol. 94
Issue:	iss. 4
Page start:	p. 519
Page end:	p. 524
Abstract:	To investigate the so-called "drift" with generic-generic drug substitution, a single-dose, four-way crossover comparative bioavailability study was performed involving 24 healthy subjects and three generic and one branded formulation of a tablet containing 800 mg gabapentin as test medication. The results showed that the 90% confidence intervals (CIs) for the area under the drug concentration-time curve (AUC0-t) and for the peak drug concentration (Cmax) were within the acceptance range of 80-125% for all comparisons. The safety profiles of the different gabapentin formulations were comparable. To conclude, all three generic formulations of gabapentin were found to be bioequivalent with the branded formulation and with each other, indicating that the formulations are interchangeable. These results strongly indicate the absence of "drift" with gabapentin generic-generic substitution.Clinical Pharmacology & Therapeutics (2013); 94 4, 519-524. doi:10.1038/clpt.2013.108.