Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (Reference-Test) | Experimental | Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 |
|
| Sequence 2 (Test-Reference) | Experimental | Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1701 | Drug | Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Amlodipine | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours |
| AUClast of Amlodipine | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours |
| Cmax of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| AUClast of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| Cmax of Rosuvastatin | Pharmacokinetic evaluation | Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |
| AUClast of Rosuvastatin | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |
| Cmax of Free Ezetimibe | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Total Ezetimibe | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |
| AUClast of Total Ezetimibe | Pharmacokinetic evaluation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Hospital (Anam) | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38775910 | Derived | Park JW, Chung H, Kim JM, Kim NY, Hong SH, Kim KA, Park JY. Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. Drugs R D. 2024 Jun;24(2):179-186. doi: 10.1007/s40268-024-00460-y. Epub 2024 May 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HCP1306 | Drug | Ezetimibe /Rosuvastatin |
|
| HGP0904 | Drug | Amlodipine |
|
| HGP0608 | Drug | Losartan potassium |
|
| AUClast of Free Ezetimibe | Pharmacokinetic evaluation | Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |
| Cmax of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| AUClast of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours |
| Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |