Pharmacokinetic evaluation
BLOOD
Blood samples for pharmacokinetic evaluation were collected predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 h postdose on Day 1; predose on Days 5–12; and predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 h after the final dose on day 13. The collected blood samples (4 mL) were centrifuged at 2000 × Plasma concentrations of HP501 were determined by liquid chromatography–tandem mass spectrometry (LC-MS/MS) using an LC-30AD chromatograph (Shimadzu, Kyoto, Japan) and an API 5500 mass spectrometer (AB Sciex, Framingham, MA, United States) with HC-1239 (provided by Hinova Pharmaceuticals Inc.) as the internal standard. The lower limit of quantification was 5 ng/mL for HP501, with a calibration range of up to 5000 ng/mL.All the pharmacokinetic parameters were determined by non-compartmental analysis (NCA) using Phoenix WinNonlin software (version 8.1; Certara, Princeton, NJ, United States). The key pharmacokinetic parameters included maximum plasma concentration (C