Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans

This is a multicenter, randomized, open-label, two-drug, single-dose, four-cycle, crossover study aimed at evaluating the bioequivalence of the test formulation versus the reference formulation, trifluorouracil tepiazole tablets (20mg), in Chinese patients with solid tumors. The planned blood sampling time points: 0h (within 1 hour before administration) and 20 minutes, 40 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 20 minutes, 2 hours 40 minutes, 3 hours, 3 hours 20 minutes, 3 hours 40 minutes, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, a total of 19 points. Blood sampling time points after the meal: 0h (within 1 hour before administration) and 30 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 20 minutes, 2 hours 40 minutes, 3 hours, 3 hours 20 minutes, 3 hours 40 minutes, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, a total of 19 points.