Study Design and Drug Administration
A randomized, open, single-dose, double-cycle, two-sequence, crossover
PK-BE study was designed to be conducted in healthy Chinese subjects
under fasting and postprandial conditions. A washout period of 3 days
was observed before crossing over to prevent the carry-over effect. 108
healthy Chinese volunteers, both male and female, were enrolled in this
study, which was separated into two groups, 36 subjects for the fasting
group and 72 subjects for the postprandial group. In each group,
subjects were randomized into 2 treatment sequence groups: T-R or R-T
(where T refers to the test tablet, and R refers to the reference
tablet). The order of receiving the test and reference products for each
subject during each study period was determined according to a
randomization schedule generated by SAS 9.4 software by a
biostatistician.
In the fasting group, each subject randomly received a single dose of
the T or R tablet of 1 mg rasagiline after overnight fasting for 10
hours. In the postprandial group, each subject received a single dose of
the T or R tablet of 1 mg rasagiline with a high-fat and high-calorie
breakfast (total energy 1000 kilocalories). The study drug was
administered with 240 mL of water. Additional water intake was forbidden
1 hour before and after administration.