in 2901 patients; 2135 patients with exposure to 300 mg twice daily tablet dose including five controlled, randomized, trials (SOLO-1, SOLO-2, OlympiAD, POLO, and PROfound) and to 400 mg twice daily capsule dose in 766 patients in other trials that were pooled to conduct safety analyses....
Peak plasma time: 1.5 hr (tablet); 1-3 hr (capsule) Peak plasma concentration: 7.7 mcg/mL (tablet at steady-state) AUC: 49 mcg·hr/mL (tablet at steady-state) Steady-state achieved: 3-4 days Coadministration with a high-fat meal slowed the rate (Peak plasma time delayed by 2.5 hr...
in 2901 patients; 2135 patients with exposure to 300 mg twice daily tablet dose including five controlled, randomized, trials (SOLO-1, SOLO-2, OlympiAD, POLO, and PROfound) and to 400 mg twice daily capsule dose in 766 patients in other trials that were pooled to conduct safety analyses....