NCT06902818

Brief Summary

The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2025

Completed
Last Updated

October 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 24, 2025

Last Update Submit

September 30, 2025

Conditions

Gastric Ulcer

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-115A

    pre-dose to 24 hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-115A

    pre-dose to 24 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate)

Drug: AD-115A, AD-1151

Sequence B

EXPERIMENTAL

Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab)

Drug: AD-115A, AD-1151

Interventions

AD-115A, AD-1151DRUG

AD-115A , AD-1151 Oral Tablet

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
  • Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

You may not qualify if:

  • Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H PLUS YANGJI HOSPITAL, Seoul,

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

March 21, 2025

Primary Completion

April 25, 2025

Study Completion

May 8, 2025

Last Updated

October 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)