Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-25 @ 3:56 PM
Study NCT ID:
NCT05297968
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2022-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
Study Overview
Official Title:
Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Status:
COMPLETED
Status Verified Date:
2022-03
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:
an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.
Detailed Description:
72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h，10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.
Study Oversight
Has Oversight DMC:
True
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?: