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NCT Number: NCT07312773

A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C

To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H+ Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers aged ≥19 and <65 years at the time of the screening visit
  • Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit

Exclusion criteria

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

Treatment and study plan

Treatment A(AD-231A)

Drug

AD-231A Oral Tablet

Treatment B(AD-231B+AD-231C)

Drug

AD-231B+AD-231C Oral Tablet

Treatment C(AD-231A+AD-231B+AD-231C)

Drug

AD-231A+AD-231B+AD-231C Oral Tablet

Primary outcomes

  1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)

    Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14

    AUCτ,ss

  2. Maximum concentration of drug in plasma at steady state (Cmax,ss)

    Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

JaeHun Jung

CONTACT

[email protected]

+8247679615

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C in Healthy Adult Volunteers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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