生物学的同等性とバイオアベイラビリティのジャーナル

概要

Pharmacokinetic Comparison of Two Gabapentin Formulations in Healthy Volunteers

Wen Yao Mak, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay Yuen

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.