A Phase 1 interventional study of AD-120A and AD-120 in Gastroesophageal Reflux Disease (GERD), sponsored by Addpharma Inc.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Addpharma Inc. (part of Yuhan Corporation) · Phase 1, Interventional, and Treatment
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's planned enrollment of 48 is below the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Addpharma Inc. is the lead sponsor of 58 studies on the registry; 25 are open to participants now.
First submitted after Addpharma Inc. became part of Yuhan Corporation.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)
Drug: AD-120A · Drug: AD-120
Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)
Drug: AD-120A · Drug: AD-120
Administered before the breakfast during 7 days, Oral, Tablet
Also known as: Reference Drug
Administered before the breakfast during 7 days, Oral, Tablet
Also known as: Test drug
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
AUCτ,ss after 7days repeated administration of Omeprazole
Time frame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
The time of peak concentration after single dose
Tmax after 1days administration of Omeprazole
Time frame: Tmax: from pre-dose to 24 hours of 1st administration
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose
Time frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)
Start is estimated for Apr 2025; primary completion for Sep 2025, 4 months later.
Of 26 phase 1 interventional studies under Gastroesophageal Reflux, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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