PHARMACOKINETICS OF 8-MG GALANTAMINE HYDROBROMIDE PROLONGED-RELEASE CAPSULES UNDER FED AND FASTING CONDITIONS

To determine the pharmacokinetics of 8-mg galantamine prolonged-release capsules under fed and fasting conditions. A randomised, open-label, single-dose, two-treatment, two-period, two-sequence, parallel design of the administration of 8-mg galantamine hydrobromide prolonged-release capsules under fed and fasting conditions in 52 healthy Thai volunteers. Each subject was randomly assigned to receive a single oral dose of galantamine under fed or fasting conditions with a 7-day washout period. Blood samples were collected between 0.0 and 48.0 h following drug administration. LC-MS/MS was used for the quantitation of galantamine in plasma. Pharmacokinetics parameters were analysed including Cmax, Tmax, T1/2, ke, AUC0-48h, and AUC0-inf. 46 subjects completed the present study. The mean Cmax values were 41.95 + 10.05 ng/mL and 25.96 + 4.18 ng/mL, and the mean AUC0-48h values were 599.45 + 159.54 and 503.47 + 79.62 ng.h/mL under fed and fasting conditions, respectively. The mean AUC0-inf values under fed and fasting conditions were 620.89 + 173.95 ng.h/mL and 527.43 + 83.97 ng.h/mL, respectively.Tmax value under fed conditions was 5.70 + 1.36 h and under fasting conditions was 5.61 + 1.71 , which were not significantly different. The Cmax was 59% higher under fed conditions, with a treatment condition ratio of 1.5906,