Blood and urine sampling
BLOOD
Blood samples were collected pre-dose and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 h post-dose on Days 1 and 10, and pre-dose and 1, 1.5, 2, 3, 4, 6, 8, and 12 h after the first dose on Day 4. A 5-min deviation window was permitted for the nominal times 0–4 h, and 10 min for the nominal times 4–24 h. After collection, the blood samples were centrifuged at 3,000 rpm for 10 min, and the resultant plasma was frozen at −20°C until analysis.Urine samples were collected pre-dose and 0–4, 4–8, 8–12, 12–24, and 24–48 h post-dose on Days 1 and 10, and pre-dose and 0–4, 4–8, and 8–12 post-dose on Day 4. Subjects were encouraged to void completely within 15 min prior to dosing, and at the end of each collection interval. A 20-min deviation window was permitted. Urine was refrigerated during the collection intervals. At the end of each interval, the total urine volume was measured. The volumes were recorded, and the samples were frozen at −20°C until analysis.