Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
Study NCT ID:
NCT04335266
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2020-04-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Food Effect Study of SHR2554 on Healthy Chinese Male Adult Subjects
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open, Single-center, Two-cycle, Double-sequence Crossover Study to Investigate the Effects of a High-fat Diet on the Pharmacokinetics of Healthy Chinese Male Adult Subjects After Oral Administration of SHR2554 Tablets
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: