Evaluating the safety and interaction of two diabetes and cholesterol medications in healthy adults
A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
This study is testing how safe it is to take two diabetes and cholesterol medications together in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hyundai Pharm Industry-sponsored |
| Locations | 1 site (Daegu, Gyeongsangbuk-do) |
| Trial ID | NCT06578676 on ClinicalTrials.gov |
What this trial studies
This phase 1 trial aims to assess the pharmacokinetic interaction and safety of co-administered Empagliflozin and Ezetimibe/Rosuvastatin in healthy volunteers. The study employs an open-label, multiple-dose, two-arm design with a fixed-sequence approach. Participants will receive either Empagliflozin followed by Ezetimibe/Rosuvastatin or vice versa, with washout periods in between. The goal is to determine how these medications interact when taken together and their safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 and over with a BMI between 18.5 and 29.9.
Not a fit: Patients with pre-existing diseases that could affect drug metabolism or those with clinically relevant findings may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe co-administration of these medications, potentially improving treatment strategies for patients with Type 2 Diabetes and Dyslipidemias.
How similar studies have performed: While this study focuses on a specific interaction, similar studies evaluating drug interactions in healthy volunteers have shown promising results in understanding medication safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age: 19 and over , healthy volunteer * Body mass index (BMI): 18.5≤BMI≤29.9 kg/m² Exclusion Criteria: * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal * Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)
Where this trial is running
Daegu, Gyeongsangbuk-do
- Kyungpook national university hospital — Daegu, Gyeongsangbuk-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Young-Ran Yoon, PhD
- Email: yry@knu.ac.kr
- Phone: +82 53-200-6351
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.