RecruitingPhase 1NCT07385235

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

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


Sponsor

Addpharma Inc.

Enrollment

46 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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

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Interventions

DRUGAD-115A, AD-1151

Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.


Locations(1)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

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NCT07385235


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