Research Article
Wen Yao Mak, Siew Siew Tan,
Abstract
The objective of the study was to establish bioequivalence between a local generic against the innovator product of gabapentin 300 mg. The study design was a standard two-way crossover, open-label, randomised and single dose study in 24 healthy male volunteers under fasting condition. The washout period was 7 days between both periods to allow adequate drug elimination. Liquid chromatography tandem mass spectrometry was utilised to determine gabapentin concentration in plasma. Non-compartmental model was used to analyse Tmax, Cmax, AUC0-t, AUC0-∞, t1/2 and ke. Potential adverse events were closely monitored and recorded throughout the study. The study found all pharmacokinetic parameters were within the bioequivalence limit of 80.00%-125.00%, with minimum side effects. In conclusion, the generic product was bioequivalent to the innovator product.