Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587011
Status:
UNKNOWN
Last Update Posted:
2020-12-28
First Post:
2020-10-07
Brief Title:
A Study to Explore PharmacokineticsPharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects
Sponsor:
HK innoN Corporation
Organization:
HK innoN Corporation
Study Overview
Official Title:
A Phase 1 Clinical Trial to Explore Pharmacokinetics Pharmacodynamics and Safety After Twice-daily Dosing of Tegoprazan Tablets in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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 main purpose of this study is to explore the pharmacokinetics pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects
Detailed Description:
To explore the pharmacokinetics pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects
To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
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