Hypertension
Conditions
Brief summary
This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults
Detailed description
This randomized, open-label, 2-arm, 2-period, multiple-dose, phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of HUC2A-752 following repeated oral administration of HUC2A-752-A and HUC2A-752-B in healthy adult volunteers.
Interventions
HUC2A-752-A
HUC2A-752-B
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy adult volunteers * Individuals with a body weight between 50.0 kg and 90.0 kg and a BMI between 18.5 kg/m² and 29.9 kg/m²
Exclusion criteria
* Individuals with a history or presence of clinically significant diseases of the following systems: hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular , musculoskeletal, urological, psychiatric, or sexual dysfunction. * Individuals with a history of gastrointestinal diseases or gastrointestinal surgeries that could affect the safety or pharmacokinetic evaluation of the investigational product. * Individuals with a history of hypersensitivity or clinically significant hypersensitivity reactions to losartan, pitavastatin, ezetimibe, angiotensin receptor blockers, statins, or any other medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau,ss | Day 15 | Area Under the Curve |
| Cmax,ss | Day 15 | Maximum concentration at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax,ss | Day 15 | Time to maximum concentration at steady state |
| t1/2 | Day 15 | Half-life |
| CLss/F | Day 15 | Apparent Clearance |
| Vdss/F | Day 15 | Apparent Volume of Distribution at Steady State |
Countries
South Korea