Document Classification

Section Type: RESULTS

Text: The main pharmacokinetic parameters [mean (SD)] for ranolazine after administration of a single oral dose of 500, 1, 000, and 1, 500 mg were as follows : maximum plasma concentration (C (max)) 741. 5 (253. 0), 1, 355. 0 (502. 0), and 2, 328. 7 (890. 5) ng/mL, respectively ; area under the concentration-time curve from time zero to 48 h (AUC (48)) 9, 071. 9 (3, 400. 0), 16, 573. 5 (6, 806. 2), and 29, 324. 5 (10, 857. 2) ngh/mL ; AUC from time zero extrapolated to infinity (AUC ()) 9, 826. 7 (3, 152. 0), 16, 882. 4 (6, 790. 8), and 29, 923. 5 (10, 706. 3) ngh/mL ; time to reach C (max) (t (max)) 5. 3 (1. 4), 4. 2 (1. 2), and 5. 9 (2. 8) h ; elimination half-life (t ()) 6. 4 (3. 3), 6. 4 (3. 5), and 6. 7 (4. 3) h. Mean (SD) values for the main pharmacokinetic parameters for ranolazine after administration of multiple doses were as follows : steady-state C (max) (C (max, ss)) 1, 732. 9 (547. 3) ng/mL ; C (min, ss) 838. 1 (429. 8) ng/mL ; steady-state AUC at time t (AUC (ss, (t))) 14, 655. 5 (5, 624. 2) ngh/mL ; average steady-state plasma drug concentration during multiple-dose administration (C (av, ss)) 1, 221. 3 (468. 7) ng/mL ; t (max) 3. 46 (1. 48) h ; t () 6. 28 (2. 48) h.