Comparing the effects of two medications on healthy individuals
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
PHASE1 · Addpharma Inc. · NCT06932705
This study tests how two medications work in healthy people to see if one is safer or more effective than the other.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Addpharma Inc. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06932705 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetic characteristics and safety profiles of a medication called PA-111 compared to its coadministration with PA-111A in healthy subjects. The primary goal is to understand how these medications are processed in the body. Participants will be monitored for safety and any adverse effects during the study. The trial is designed for individuals who meet specific health criteria and are not currently involved in other clinical studies.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 19 and older with a body weight of at least 50kg (or 45kg for females) and a BMI between 18.0 and 30.0.
Not a fit: Patients currently participating in other clinical studies or those with health conditions that exclude them from eligibility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effectiveness of PA-111, potentially leading to better treatment options for mixed dyslipidemia.
How similar studies have performed: While this study focuses on a specific comparison of medications, similar pharmacokinetic studies have shown success in understanding drug profiles and safety in healthy populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- H Plus Yangji Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: JeongEun Park
- Email: parkje@addpharma.co.kr
- Phone: +82-31-891-6989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mixed Dyslipidemia