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A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nateglinide+Metformin | Active Comparator | coadministration of nateglinide and metformin |
|
| Nateglinide/Metformin | Experimental | Nateglinide/Metformin tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nateglinide | Drug |
| ||
| Nateglinide/Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| AUC last | 0-~24hrs | |
| Cmax | 0~24hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam University Hospital | Daejeon | South Korea |
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|
| Metformin | Drug |
|
| ID | Term |
|---|---|
| D000077715 | Nateglinide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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