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

Phase 1Not Yet RecruitingNCT07715305

Addpharma Inc.44 enrolled

Overview

The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Interventions

AD-116ADRUG

Oral Capsule

AD-1161DRUG

Oral Capsule

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

Outcomes

Primary Outcomes

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

AUCt of AD-116A

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

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-116A

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

Central Contacts

Soyoung Hwang

CONTACT

+82-31-891-6919 syhwang@addpharma.co.kr

Data from ClinicalTrials.gov

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