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A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)
[Objectives] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions
[Admission and Confinement] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.
Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC Zemimet® SR Tab. 50/1000(Fasting) | Active Comparator | Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition |
|
| FDC Zemimet® SR Tab. 50/1000(Fed) | Active Comparator | Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) | Drug | Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin | The observed maximum or peak concentration after administration of the drug | Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 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 and 48.00 hours post-dose. |
| AUC0-tlast of gemigliptin, LC 15-0636 and metformin | Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured | Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 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 and 48.00 hours post-dose. |
| AUC0-∞ of gemigliptin, LC 15-0636 and metformin | Area under the concentration-time curve from time zero to infinity by the extrapolation of the rest of AUC from last time where plasma concentration can be measured to time infinity | Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 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 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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| Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) | Drug | Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast. |
|
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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