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NCT Number: NCT07722871

A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers

This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.

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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

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 50 kg and body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • Age equal to or greater than 19 years in healthy adult male volunteers at the time of screening visit

Exclusion criteria

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

Treatment and study plan

AD-116A

Drug

Oral Capsule

AD-1161

Drug

Oral Capsule

Primary outcomes

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

    Time frame: [Time Frame: pre-dose (0hour) to 48hours]

    AUCt of AD-116A

Secondary outcomes

  1. 2. Maximum concentration of drug in plasma (Cmax)

    Time frame: [Time Frame: pre-dose (0hour) to 48hours]

    Cmax of AD-116A

Study contacts

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

TaeBin Jeong

CONTACT

[email protected]

+82-31-605-7641

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 Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 27, 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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