Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-05 @ 12:43 PM
Study NCT ID:
NCT03009760
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
Sponsor:
HK inno.N Corporation
Organization:
Study Overview
Official Title:
A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
Status:
COMPLETED
Status Verified Date:
2017-01
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 compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.
Detailed Description:
1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
Study Oversight
Has Oversight DMC:
False
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?: