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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07722871

Enrollment

Registered

2026-07-23

Start date

2026-07-01

Completion date

2026-10-01

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Brief summary

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

Interventions

DRUGAD-116A

Oral Capsule

DRUGAD-1161

Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
1. Area under the plasma concentration-time curve during dosing interval (AUCt)	[Time Frame: pre-dose (0hour) to 48hours]	AUCt of AD-116A

Secondary

Measure	Time frame	Description
2. Maximum concentration of drug in plasma (Cmax)	[Time Frame: pre-dose (0hour) to 48hours]	Cmax of AD-116A

Countries

South Korea

Contacts

CONTACTTaeBin Jeong

tbjeong@addpharma.co.kr+82-31-605-7641

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026