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[Objectives]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (ZemimetĀ® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions Secondary: To evaluate safety of test and reference formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test: Gemigliptin/Metformin | Active Comparator | Fixed Dose Combination ZemimetĀ® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) |
|
| Reference: Gemigliptin and Metformin | Active Comparator | Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release | Drug | Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin. Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base). |
| Measure | Description | Time Frame |
|---|---|---|
| bioequivalence study | To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (ZemimetĀ® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions | Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 32.00 and 48.00 hours post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunjoo Cho | Contact | +82-2-6987-4284 | eunjoo.cho@lgchem.com | |
| Sirin Khantichaikajon | Contact | +66-2-654-2323 | 118 | sirink@lgchem.com |
| Name | Affiliation | Role |
|---|---|---|
| Uthai Suvanakoot | International Bio Service Co., Ltd. | Principal Investigator |
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|
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| Gemigliptin tartrate sesquihydrate and metformin | Drug | Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg. |
|
|
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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