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The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 of Study A | Experimental | single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755 |
|
| Group 2 of Study A | Experimental | single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin |
|
| Group 1 of Study B | Experimental | single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast |
|
| Group 2 of Study B | Experimental | single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin, Metformin, YH14755 | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of rosuvastatin and metformin | 0~48hr, totally 17 points | |
| Cmax of rosuvastatin and metformin | 0~48hr, totally 17 points |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of rosuvastatin and metformin | 0~48hr, totally 17 points | |
| t1/2 of rosuvastatin and metformin | 0~48hr, totally 17 points | |
| %AUC of rosuvastatin and metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim, MD, Ph.D | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 561712 | South Korea |
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| YH14755 | Drug | single dose |
|
| 0~48hr, totally 17 points |
| AUCinf of rosuvastatin and metformin | 0~48hr, totally 17 points |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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