A Clinical Trial to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07103278

Enrollment

Registered

2025-08-05

Start date

2026-01-22

Completion date

2026-03-07

Last updated

2026-07-28

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

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers

Interventions

DRUGAD-116

AD-116 Oral Tablet

DRUGAD-1161

AD-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 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026