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A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers
A randomized, open-label, single dose, crossover clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310 |
|
| Group II | Experimental | Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin + Rosuvastatin | Drug | administration of Metformin + Rosuvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Metformin and rosuvastatin | 48 hours | |
| Cmax of Metformin and rosuvastatin | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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| JLP-1310 | Drug | administration of JLP-1310 |
|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| 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 |