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.