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

Addpharma

Status and phase: Enrolling; Phase 1

Conditions: Mixed Dyslipidemia

Treatments: Drug: PA-111; Drug: PA-111A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06932705

PA-111BE

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sequence A (RT)

Experimental group

Description:

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

Treatment:

Drug: PA-111A

Drug: PA-111

Sequence A (TR)

Experimental group

Description:

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

Treatment:

Drug: PA-111A

Drug: PA-111