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Completed

NCT Number: NCT07495514

A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

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Key information

Conditions

Mixed Dyslipidemia Food Effect Study of AD-117

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H PLUS YANGJI HOSPITAL, Seoul,

Seoul, South Korea

About this study

An open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the food effect on the safety and the pharmacokinetics of AD-117 in healthy adult volunteers

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • Healthy volunteers aged ≥19 and <65 years at the time of 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

AD-117

Drug

AD-117 1Tab., Per Oral

Primary outcomes

  1. Maximum concentration of drug in plasma (Cmax)

    Time frame: 0-72 hours

    Cmax of AD-117

  2. Area under the plasma concentration-time curve during dosing interval (AUCt)

    Time frame: 0-72 hours

    AUCt of AD-117

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of AD-117 in Healthy Adult Volunteers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Jul 15, 2026

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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