NCT07722871

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Jul 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jul 2026Oct 2026

Study Start

First participant enrolled

July 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 20, 2026

Last Update Submit

July 24, 2026

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

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

    AUCt of AD-116A

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Sequence A(RT)

EXPERIMENTAL

Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116A)

Drug: AD-116ADrug: AD-1161

Sequence B(TR)

EXPERIMENTAL

Period 1 : Test Drug(AD-116A), Period 2 : Reference Drug(AD-1161)

Drug: AD-116ADrug: AD-1161

Interventions

AD-116ADRUG

Oral Capsule

Sequence A(RT)Sequence B(TR)
AD-1161DRUG

Oral Capsule

Sequence A(RT)Sequence B(TR)

Eligibility Criteria

Age19 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsGender Eligibility Description:
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

TaeBin Jeong

CONTACT

+82-31-605-7641tbjeong@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

July 20, 2026

First Posted

July 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

KR(1)