Comparing the effects of two medications on healthy individuals
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
Run by Addpharma Inc. · NCT06932705 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | April 2025 |
| Main results expected | May 2025 |
| Study ends | May 2025 |
| Registry record updated | April 17, 2025 |
| Trial ID | NCT06932705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
H Plus Yangji Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: JeongEun Park
- Email: parkje@addpharma.co.kr
- Phone: +82-31-891-6989
Similar studies
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This study is testing if a new drug called AD-218 can help people with mixed dyslipidemia improve their cholesterol levels and overall health.
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Leqvio (inclisiran) post-marketing surveillance in Korea
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.