Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623526
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Clinical Trial to Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Fasting Single-Crossover Study to Compare the Pharmacokinetic Interactions and Safety of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers
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 crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects
Detailed Description:
26 healthy subjects will be randomized to one of the 2 groups in the same ratio
YHR2402 and YHR2402YHR2403 will be administered to Subjects in group 1 by crossover design on day 1 15
YHR2402YHR2403 and YHR2402 will be administered to Subjects in group 2 by crossover design on day 1 15
YHR2402 and YHR2402YHR2403 will be administered to Subjects in group 1 by crossover design on day 1 15
YHR2402YHR2403 and YHR2402 will be administered to Subjects in group 2 by crossover design on day 1 15
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