Healthy Volunteer Clinical Trial
Official title:
A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.
This study will be an open-label, randomized, two-period, crossover PK food effect study of
SHC014748M Capsules administered orally at 200 mg.
For each of 2 study periods, subjects will be admitted to the clinical research unit on the
day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for
each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M
Capsules in either the fasted or fed state. Subjects will remain at the clinical research
unit for at least 72 hours after administration of study drug for collection of serial blood
samples for pharmacokinetic (PK) analysis and safety monitoring.
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