Status:

COMPLETED

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

Lead Sponsor:

Addpharma Inc.

Conditions:

Gastric Ulcer

Eligibility:

All Genders

19+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 8 2025

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT06902818

Start Date

March 21 2025

End Date

May 8 2025

Last Update

October 3 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

H PLUS YANGJI HOSPITAL, Seoul,

Seoul, South Korea