Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359626
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-04-07
Brief Title:
Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers
Sponsor:
Yuhan Corporation
Organization:
Yuhan Corporation
Study Overview
Official Title:
An Open-label Randomized Single-dose Oral Administration 2-sequence 2-period Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-07
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:
A randomized open-label single-dose 2-sequence 2-period crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
Detailed Description:
60 healthy subjects will be randomized to one of the 2 groups in the same ratio
Subjects in group 1 will be administered YHP2205 and comparator by cross-over design on day 1 8
Subjects in group 2 will be administered comparator and YHP2205 by cross-over design on day 1 8
Subjects in group 1 will be administered YHP2205 and comparator by cross-over design on day 1 8
Subjects in group 2 will be administered comparator and YHP2205 by cross-over design on day 1 8
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