title: Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study.
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 (AUC(0-t)) and for the peak drug concentration (C(max)) 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.
authors.affiliation: 1] Department of Pharmacology, Maastricht University Medical Centre, Maastricht, The Netherlands [2] Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Y
authors.initials: Y
authors.lastname: Yu
authors.forename: S
authors.initials: S
authors.lastname: Teerenstra
authors.forename: F
authors.initials: F
authors.lastname: Vanmolkot
authors.forename: C
authors.initials: C
authors.lastname: Neef
authors.forename: D
authors.initials: D
authors.lastname: Burger
authors.forename: M
authors.initials: M
authors.lastname: Maliepaard
mesh_terms: D000328:Adult; D000588:Amines / Q000009:adverse effects / Q000493:pharmacokinetics*; D000927:Anticonvulsants / Q000493:pharmacokinetics*; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000493:pharmacokinetics*
chemical_list: D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D013607:Tablets; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin