Comparing the effects of two medications for high cholesterol
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06884098 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 19 and older with a body weight of at least 50 kg.
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.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with high cholesterol.
How similar studies have performed: Other studies have shown success in evaluating pharmacokinetic profiles of similar medications, suggesting this approach is promising.
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 other 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.