The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2025-05-08

Brief Summary

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

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Detailed Description

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A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state

Conditions

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Gastric Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

AD-115A, AD-1151

Intervention Type DRUG

AD-115A , AD-1151 Oral Tablet

Sequence B

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

Group Type EXPERIMENTAL

AD-115A, AD-1151

Intervention Type DRUG

AD-115A , AD-1151 Oral Tablet

Interventions

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AD-115A, AD-1151

AD-115A , AD-1151 Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* Other exclusions applied

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No