Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332638
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-27
First Post:
2024-02-20
Brief Title:
PK PD and Safety of Tegoprazan 125 mg After Oral Administration in Healthy Subjects
Sponsor:
HK innoN Corporation
Organization:
HK innoN Corporation
Study Overview
Official Title:
Phase 1 Clinical Trial to Explore Pharmacokinetics Pharmacodynamics and Safety of Tegoprazan 125 mg After Oral Administration in Healthy Subjects
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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 primary objective of this study is to explore pharmacokinetics pharmacodynamics and safety of tegoprazan 125 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily
Detailed Description:
The secondary objectives of this study are
To compare pharmacokinetics and pharmacodynamics of tegoprazan 125 mg in healthy subjects between oral multiple-dose administration twice daily for 1 day and oral single-dose administration
To evaluate pharmacokinetics and pharmacodynamics of tegoprazan 125 mg administered orally twice daily for 14 days in healthy subjects in comparison with tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects
To evaluate pharmacodynamics of tegoprazan 125 mg administered orally twice daily for 14 days or tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects in comparison with famotidine 20 mg administered orally twice daily for 14 days in healthy subjects
To compare pharmacokinetics and pharmacodynamics of tegoprazan 125 mg in healthy subjects between oral multiple-dose administration twice daily for 1 day and oral single-dose administration
To evaluate pharmacokinetics and pharmacodynamics of tegoprazan 125 mg administered orally twice daily for 14 days in healthy subjects in comparison with tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects
To evaluate pharmacodynamics of tegoprazan 125 mg administered orally twice daily for 14 days or tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects in comparison with famotidine 20 mg administered orally twice daily for 14 days in healthy subjects
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