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A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.
A randomized, open-label, single dose, crossover clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JLP-1310, Fasted followed by fed | Experimental | JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310 |
|
| JLP-1310, Fed followed by fasted | Experimental | JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JLP-1310, Fasted followed by fed | Drug | In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 48 hours from baseline | |
| AUC(last) | 48 hours from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(inf) | 48 hours from baseline | |
| Tmax | 48 hours from baseline | |
| T1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Heon Cho, MD., Ph.D | Inha University Hospital | Principal Investigator |
| 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, Fed followed by fasted | Drug | In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition. |
|
|
| 48 hours from baseline |
| CL/F | 48 hours from baseline |
| Vd/F | 48 hours from baseline |
| 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 |