Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04006860
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT04006860
Study Brief:
Protocol Section:
NCT04006860