The Food Effect on PK Characteristics and Safety Profiles of PA-111

Phase 1Not Yet RecruitingNCT06976489

Addpharma Inc.40 enrolled

Overview

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

The purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of PA-111 in healthy adult subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mixed Dyslipidemia

Interventions

PA-111DRUG

PA-111 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 PA-111

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

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

AUCt of PA-111

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

Central Contacts

JeongEun Park

CONTACT

+82-31-891-6989 parkje@addpharma.co.kr

Data from ClinicalTrials.gov

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