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

Phase 1

Not yet recruiting

• Conditions: Gastric Ulcer
• Interventions: Drug: AD-115A, AD-1151

• Registration Number: NCT06902818
• Lead Sponsor: Addpharma Inc.

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.

Detailed Description

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

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-21
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-09-08
• Study Completion: 2025-09-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	AD-115A, AD-1151	Period 1 : Reference Drug(AD-1151), Period 2 : Test Drug(A115A)
Sequence B	AD-115A, AD-1151	Period 1 : Test Drug(AD-115A), Period 2 : Reference Drug(AD-1151)

Primary Outcome Measures

Name	Time	Method
Maximum concentration of drug in plasma (Cmax)	pre-dose to 24 hours	Cmax of AD-115A
Area under the plasma concentration-time curve during dosing interval (AUCt)	pre-dose to 24 hours	AUCt of AD-115A