Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613139
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Single-dose Oral Administration 2-sequence 2- Period Crossover Study to Evaluate Bioequivalence Between YHP2305 and YHR2404 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label randomized single-dose oral administration 2-sequence 2- period crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects
Detailed Description:
Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1 8
Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1 8
Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None