Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090474
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2023-10-06
Brief Title:
Multiple Dose Study to Evaluate Drug-drug Interactions Safety and Tolerability of NDC-002 in Healthy Volunteers
Sponsor:
Dr Noah Biotech Inc
Organization:
Dr Noah Biotech Inc
Study Overview
Official Title:
An Open-label One-sequence Three-period Multiple-dose Study to Evaluate Drug-drug Interactions Safety and Tolerability Between NDC-002ANDC-002B and NDC-002C in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-10
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:
An Open-label One-sequence Three-period Multiple-dose Study to Evaluate Drug-drug Interactions Safety and Tolerability between NDC-002ANDC-002B and NDC-002C in Healthy Volunteers
Detailed Description:
This is an Open-label One-sequence Three-period Multiple-dose Study and the goal of this clinical trial is to evaluate in health Volunteers
The main questions it aims to answer are
Drug-drug Interactions
Safety
Tolerability
The study consisted of Three-period Period 1 which repeated administration of NDC-002C for 7 days and Period 2 which repeated administration of NDC-002A for 7 days followed by administration of NDC-002B for 8 days and Period 3 which repeated concomitant administration of NDC-002B and NDC-002C for 7 days
The main questions it aims to answer are
Drug-drug Interactions
Safety
Tolerability
The study consisted of Three-period Period 1 which repeated administration of NDC-002C for 7 days and Period 2 which repeated administration of NDC-002A for 7 days followed by administration of NDC-002B for 8 days and Period 3 which repeated concomitant administration of NDC-002B and NDC-002C for 7 days
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