Comparing the effects of two medications for high cholesterol
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers
Run by Addpharma Inc. · NCT06884098 · Data updated 2026-11-12
This study tests how two different medications for high cholesterol affect healthy volunteers to see which one is safer and works better in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | April 2025 |
| Study ends | April 2025 |
| Registry record updated | March 20, 2025 |
| Trial ID | NCT06884098 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 50 kg.
✕Probably not a fit
Patients with existing health conditions or those who have participated in other clinical studies within the last six months 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 two medications, AD-228B and AD-2284, in healthy volunteers. The primary goal is to determine how these drugs are absorbed, distributed, metabolized, and excreted in the body. Participants will be monitored for safety and any adverse effects during the study. The findings will help inform future treatments for primary hypercholesterolemia.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with high cholesterol.
How similar studies have gone: Other studies have shown success in evaluating pharmacokinetic profiles of similar medications, suggesting this approach is promising.
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 other 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Bempedoic Acid With Ezetiimibe in Adults with High Cholesterol or Mixed Dyslipidemia
This study tests bempedoic acid alone or with ezetimibe in real-world adults with primary hypercholesterolemia or mixed dyslipidemia to see how safe and effective it is in routine care.
-
Safety and how the body handles AD-116 and AD-1161 in healthy adult men
This will test how safe AD-116 and AD-1161 are and how the body processes them in healthy adult men after a meal.
-
Single-dose safety and blood-level comparison of AD-115A versus AD-1151 in healthy adults
This test will see if a single dose of AD-115A or AD-1151 is safe and how each drug is absorbed and cleared in healthy adults.
-
Comparing the effects of two medications on healthy individuals
This study tests how two medications work in healthy people to see if one is safer or more effective than the other.
-
Evaluating the effects of two medications for high blood pressure
This study is testing whether a combination of two new medications can help people with high blood pressure feel better and stay safe.
-
Evaluating the effectiveness and safety of AD-218 for mixed dyslipidemia
This study is testing if a new drug called AD-218 can help people with mixed dyslipidemia improve their cholesterol levels and overall health.
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.