With the final model, 2 × 2 crossover trial scenarios with Nexavar ® 200 mg and each dose of SYO-1644 ranging from 100 to 150 mg were repeated 500 times by Monte Carlo simulation, and the proportion of bioequivalence achievement was assessed. The PK profile was evaluated by both non-compartmental analysis and population PK method. Pharmacokinetic (PK) samples were collected up to 168 h post-dose. A total of 32 subjects orally received a single dose of the following assigned treatment under a fasted state in the first period and repeated once more in the second period with a two-week washout: SYO-1644 100, 150 and 200 mg and Nexavar ® 200 mg. To evaluate the pharmacokinetically equivalent dose of SYO-1644 to the reference Nexavar ® 200 mg, a randomized, open-label, replicated two-period study was conducted in healthy volunteers. ![]() SYO-1644 improved the solubility of sorafenib by nanoparticulation technology leading to enhanced bioavailability. Sorafenib, an oral multikinase inhibitor, exhibits a highly variable absorption profile due to enterohepatic reabsorption and poor solubility.
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