NCT07444385

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 26, 2026

Last Update Submit

March 1, 2026

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

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

    AUCt of AD-116

    pre-dose (0hour) to 72hours

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-116

    pre-dose (0hour) to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.

Drug: AD-116, AD-1161

Sequence B

EXPERIMENTAL

Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2.

Drug: AD-116, AD-1161

Interventions

AD-116, AD-1161DRUG

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

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

JaeHun Jung

CONTACT

+82-31-891-5683jhjung@addpharma.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 2, 2026

Study Start

February 26, 2026

Primary Completion

April 22, 2026

Study Completion

May 8, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)