A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282

Addpharma Inc.60 enrolled

Overview

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Hypercholesterolaemia

Interventions

AD-228ADRUG

AD-228A Oral Tablet

AD-2281 and AD-2282DRUG

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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: * Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied

Locations (1)

H+ Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-228A

Time frame: pre-dose to 72 hours

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

AUCt of AD-228A

Time frame: pre-dose to 72 hours

Data from ClinicalTrials.gov

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