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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

Period 1: Fasted, Period 2: Fed

Group Type EXPERIMENTAL

PA-111

Intervention Type DRUG

PA-111 1Tab., Per Oral

Sequence B

Period 1: Fed, Period 2: Fasted

Group Type EXPERIMENTAL

PA-111

Intervention Type DRUG

PA-111 1Tab., Per Oral

Interventions

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PA-111

PA-111 1Tab., Per Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes