A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
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, PA-111A.
- 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 Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
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 evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.
Interventions
- Drug PA-111
PA-111 1Tab., Per Oral - Drug PA-111A
PA-111A 1Capsule., 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: NCT06932705 · PA-111BE