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Not yet recruiting NCT06976489

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

Phase I Interventional Mixed Dyslipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PA-111.
Who it may be relevant to
Registry conditions: Mixed Dyslipidemia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of PA-111 in Healthy Adult Volunteers

Overview

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

Detailed description

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.

Interventions

  • Drug PA-111
    PA-111 1Tab., Per Oral

Primary outcome measures

  • Maximum concentration of drug in plasma (Cmax) [Time frame: pre-dose (0hour) to 72hours]
  • Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: pre-dose (0hour) to 72hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • H Plus Yangji Hospital — Seoul

Identifiers

NCT: NCT06976489 · PA-111FE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗