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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

AD-116

Intervention Type DRUG

AD-116 Oral Tablet

AD-1161

Intervention Type DRUG

AD-1161 Oral Capsule

Sequence B

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

Group Type EXPERIMENTAL

AD-116

Intervention Type DRUG

AD-116 Oral Tablet

AD-1161

Intervention Type DRUG

AD-1161 Oral Capsule

Interventions

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AD-116

AD-116 Oral Tablet

Intervention Type DRUG

AD-1161

AD-1161 Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes