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
Not provided
Not provided
To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab |
|
| Sequence 2 | Experimental | R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1105 | Drug |
| ||
| HCP0918 |
| Measure | Description | Time Frame |
|---|---|---|
| baseline-corrected Cmax of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | |
| baseline-corrected AUCt of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | |
| Cmax of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | |
| AUCt of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | |
| AUCt of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
•Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea |
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| HCP0816 | Drug |
|
| Tmax of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) |
| t1/2β of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) |
| baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) |
| AUC∞ of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |
| Tmax of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |
| t1/2β of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |
| CL/F of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |
| Vdz/F of Rosuvastatin | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |