PK evaluation
SAD
BLOOD
Whole blood samples were collected at a phase I clinical research center. Blood samples were taken at the following time points:
SAD and FE—pre-dose and 0.083, 0.167, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 h post-dose.MAD—days 1 and 9: pre-dose and 0.083, 0.167, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 h post-dose; days 6, 7, and 8: pre-morning dose.Liquid chromatography-tandem mass spectrometry (LC–MS/MS) was used for the determination and semi-quantitative analysis of AD16 and its possible metabolites in plasma, urine, and feces.Various PK parameters were evaluated, including time to reach peak plasma concertation (