Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703984
Status:
RECRUITING
Last Update Posted:
2023-01-30
First Post:
2023-01-19
Brief Title:
A Study to Evaluate the Safety PK of GC2129A in Healthy Volunteers Under Fasting Conditions
Sponsor:
GC Biopharma Corp
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions
Status:
RECRUITING
Status Verified Date:
2023-01
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 evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers
Detailed Description:
This study is an open-label randomized fasting single-dose 2-group 2-period crossover design to evaluate pharmacokinetics that are not affected by blinding According to the order of administering the investigational drug for each period 25 people are assigned to each of the two groups and administered
For healthy subjects each 25 subjects are assigned to each of the two groupstotal 50 subjects If the subject administrate GC2129A in the first stage the subject will be administrated reference drugs in the second stage after washoutover 7 weeks Conversely if the subject administrate reference drugs in the first stage the subject will be administrated with GC2129A in the second stage
For healthy subjects each 25 subjects are assigned to each of the two groupstotal 50 subjects If the subject administrate GC2129A in the first stage the subject will be administrated reference drugs in the second stage after washoutover 7 weeks Conversely if the subject administrate reference drugs in the first stage the subject will be administrated with GC2129A in the second stage
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