Blood Sampling and Medical Supervision
Pharmacokinetics Blood samples (4mL each) for pharmacokinetic analysis
of rasagiline were collected 1 hour pre-dose and at 5, 10, 20, 30, and
45 minutes, and 1.0, 1.33, 1.67, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0
hours post-dose in postprandial group. While in the fasting group, blood
samples were collected at the following time points: 1 hour pre-dose and
at 5, 10, 15, 20, 30 and 45 minutes, and 1.0, 1.25, 2.0, 3.0, 4.0, 6.0,
8.0, 10.0 hours.
Subjects were confined to the study center for continuous medical
supervision until all PK blood samples were collected the next day after
the second period of administration. Safety assessments included
physical examination, vital signs, ECG recording, adverse event (AE)
reporting, clinical laboratory measures and concomitant medication
reporting.