A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

NCT ID: NCT06932705

Last Updated: 2025-04-17

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-05-31

Brief Summary

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

Detailed Description

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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy 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 (RT)

Period 1: Reference (PA-111A), Period 2: Test (PA-111)

Group Type EXPERIMENTAL

PA-111

Intervention Type DRUG

PA-111 1Tab., Per Oral

PA-111A

Intervention Type DRUG

PA-111A 1Capsule., Per Oral

Sequence A (TR)

Period 1: Test (PA-111), Period 2: Reference (PA-111A),

Group Type EXPERIMENTAL

PA-111

Intervention Type DRUG

PA-111 1Tab., Per Oral

PA-111A

Intervention Type DRUG

PA-111A 1Capsule., Per Oral

Interventions

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PA-111

PA-111 1Tab., Per Oral

Intervention Type DRUG

PA-111A

PA-111A 1Capsule., 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

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H Plus Yangji Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JeongEun Park

Role: CONTACT

+82-31-891-6989

Facility Contacts

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SeungHyun Kang

Role: primary

+82-70-4665-9490

Other Identifiers

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PA-111BE

Identifier Type: -

Identifier Source: org_study_id

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