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:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT04301804
Brief Summary:
This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers
Detailed Description:
The objective of this study is to determine the comparative pharmacokinetics, safety and tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting conditions.
Each subject will receive a single dose of SHR6390, blood samples will be collected before dosing and at various time points up to 144 hours after drug administration, safety and the statistical analysis of the pharmacokinetic data will be obtained from this study
Study:
NCT04301804
Study Brief:
Protocol Section:
NCT04301804