Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study
Publication year
2013Source
Clinical Pharmacology and Therapeutics, 94, 4, (2013), pp. 519-24ISSN
Related links
23708746
Publication type
Article / Letter to editor

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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. 24
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 careAbstract
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.
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