Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318845
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
Sponsor:
Daehwa Pharmaceutical Co Ltd
Organization:
Daehwa Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interaction of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers
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:
The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants
Detailed Description:
This is a phase 1 open-label multiple doses 6-sequence 3-period and crossover study to evaluate the safety and pharmacokinetic drug interaction following 7 days of DHP2302R1 75 mg and DHP2302R2 50 mg in healthy South Korean adult participants
A total of 42 participants 7 per 6 groups will enroll in the study The participants will take 7 days of DHP2302R1 75 mg DHP2302R1 50 mg alone or in combination and 2 weeks of washout period at each period
A total of 42 participants 7 per 6 groups will enroll in the study The participants will take 7 days of DHP2302R1 75 mg DHP2302R1 50 mg alone or in combination and 2 weeks of washout period at each period
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