A Study to Compare to PK Characteristics and Safety Profiles Between AD-117 and AD-117A

Phase 1Not Yet RecruitingNCT07152873

Addpharma Inc.60 enrolled

Overview

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-117 in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mixed Dyslipidemia

Interventions

AD-117DRUG

AD-117 1Tab., Per Oral

AD-117ADRUG

AD-117A 1Tab., Per Oral

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight equal to or greater than 50kg (Female 45kg) 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: * 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, South Korea

Outcomes

Primary Outcomes

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-117

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

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

AUCt of AD-117

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

Central Contacts

Dasom Kim

CONTACT

+82-31-891-5572 dskim@addpharma.co.kr

Data from ClinicalTrials.gov

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