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

Phase 1RecruitingNCT07444385

Addpharma Inc.44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Interventions

AD-116, AD-1161DRUG

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

Eligibility

Sex: MALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

AUCt of AD-116

Time frame: pre-dose (0hour) to 72hours

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-116

Time frame: pre-dose (0hour) to 72hours

Central Contacts

JaeHun Jung

CONTACT

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

Data from ClinicalTrials.gov

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