\[Objectives\]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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).
Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.
bioequivalence study
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® 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
Time frame: 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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