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Clinical Trials in South Korea / NCT07444385
Recruiting Phase 1

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

NCT07444385 · tracked via the Priya Life Science South Korea tracker
Sponsor
Addpharma Inc
Phase
Phase 1
Started
2026-02-26
Last updated
2026-03-03

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

AD-116, AD-1161

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

Study summary

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

Eligibility

Sex
MALE
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Area under the plasma concentration-time curve during dosing interval (AUCt) — pre-dose (0hour) to 72hours
    AUCt of AD-116
  • Maximum concentration of drug in plasma (Cmax) — pre-dose (0hour) to 72hours
    Cmax of AD-116

Trial sites (1)

FacilityCityRegionStatus
H PLUS YANGJI HOSPITAL, Seoul Seoul South Korea Recruiting

More Addpharma Inc. trials in South Korea

A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284 Recruiting
A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers Starting soon
A Clinical Trial to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Starting soon
A Study to Compare to PK Characteristics and Safety Profiles Between AD-117 and AD-117A Starting soon
A Study to Evaluate the Efficacy and Safety of AD-218 Recruiting

Other trials for the same condition

A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers Starting soon
A Clinical Trial to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Starting soon
Study on Water Vapor Thermal Therapy Recruiting
BPH Global Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07444385 on ClinicalTrials.gov ↗ ← All trials in South Korea