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NCT Number: NCT07444385

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

Location status: Recruiting

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 and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • The Age equal to or greater than 19 in healthy adult male volunteers 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-116, AD-1161

Drug

Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.

Primary outcomes

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

    Time frame: pre-dose (0hour) to 72hours

    AUCt of AD-116

  2. Maximum concentration of drug in plasma (Cmax)

    Time frame: pre-dose (0hour) to 72hours

    Cmax of AD-116

Study contacts

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

JaeHun Jung

CONTACT

[email protected]

+82-31-891-5683

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 3, 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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