A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B

Phase 1CompletedNCT05202405

Addpharma Inc.64 enrolled

Overview

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipidemias

Interventions

AD-221DRUG

AD-221 Oral Tablet

AD-221A and AD-221BDRUG

AD-221A Oral Tablet + AD-221B Oral Tablet

Eligibility

Sex: ALLMin 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 volunteers at the time of screening visit Exclusion Criteria: * Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * Subjects who judged ineligible by the investigator

Locations (1)

H+ Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Cmax of AD-221

Time frame: pre-dose to 72 hours

Area Under the Curve in time plot (AUCt)

AUCt of AD-221

Time frame: pre-dose to 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.