Drug-drug Interactions
Conditions
Keywords
Drug-Drug Interactions
Brief summary
This study aims to evaluate the pharmacokinetic interactions between HUC2-744-A and HUC2-744-B following monotherapy or co-administration under multiple-dose conditions.
Detailed description
For selected subjects, the designated investigational products are administered orally with 200 mL of water during Treatment 1 (HUC2-744-A), Treatment 2 (HUC2-744-B), and Treatment 3 (HUC2-744-A + HUC2-744-B).
Interventions
HUC2-744-A
HUC2-744-B
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy adults * Subjects with a body weight of 50 kg or more and a BMI within the range of 18.0 to 29.9 kg/m²
Exclusion criteria
* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease * Presence of acute disease symptoms within 28 days prior to the first dosing * History of any disease that may affect drug absorption, distribution, metabolism, or excretion * Hypersensitivity or history of clinically significant hypersensitivity to atorvastatin, telmisartan, drugs containing ingredients of the same class, or other medications (e.g., aspirin, antibiotics, dihydropyridine derivatives)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCτ | Day 22 | Area Under the Curve of telmisartan, atorvastatin |
| Cmax,ss | Day 22 | Maximum concentration at steady state of telmisartan, atorvastatin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss | Day 22 | Maximum concentration at steady state of 2-hydroxy atorvastatin |
| AUCτ | Day 22 | Area Under the Curve of 2-hydroxy atorvastatin |
Countries
South Korea