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The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.
Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration |
|
| Rosuvastatin | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin |
|
| Co-administration | Experimental | Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin,1000mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss, AUCÏ„ | 32h |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss | 32h | |
| t1/2 | 32h | |
| Cmin,ss | 32h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-ryul Kim, MD, Ph.D | Samsung Medical Center(SMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center(SMC) | Seoul | Gangnam-Gu | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013449 |
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| Rosuvastatin | Drug | Rosuvastatin, 20 mg, once daily |
|
|
| Metformin and Rosuvastatin | Drug | Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily |
|
|
| CL/Fss | 32h |
| Vd/Fss | 32h |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| Sulfonamides |
| D000577 | Amides |
| 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 |