Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616716
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-11-02
Brief Title:
A Food Effect Study of FMTN on Healthy Chinese Adult Subjects
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A RandomizedOpenSingle-centerThree-cycleSix-sequence Crossover Study to Investigate the Effects of a High-fat and Low-fat Diet on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of FMTN Tablets
Status:
COMPLETED
Status Verified Date:
2020-10
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 was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects
The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects
The secondary objective of the study was to assess the safety of FMTN administered in adult 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?:
None