Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823883
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-04-10
Brief Title:
This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics PK After Administration of DW6014 and Each Component in Healthy Adult Volunteers in Fed Condition
Sponsor:
Dong Wha Pharmaceutical Co Ltd
Organization:
Dong Wha Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed Dose Combination of DW6014 and Loose Combination of Each Component in Healthy Adult Volunteers in Fed Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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:
This study is to compare and evaluate the safety and pharmacokinetic characteristics PK after administration of DW6014 and each component in healthy adult volunteers in fed condition
Detailed Description:
This is a Phase 1 randomized open-label Oral Single-dose two-way crossover study in healthy subjects
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