Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover Bioequivalence Study of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) and Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage® XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) Under Fasting Conditions in Healthy Volunteers

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Gemigliptin tartrate sesquihydrate and metformin
* Drug: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18.0 to 30.0 kg/m2. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Non-pregnant woman (negative pregnancy test) and not currently breast feeding Female subjects abstain from either hormonal methods of contraception Male subjects who are willing or able to use effective contraceptive Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study. Exclusion Criteria: History serious hypersensitivity reactions History or evidence of clinically significant diseases or any significant ongoing chronic medical illness History or evidence of family diabetes History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma History or evidence of shock or severe dehydrate or severe infection History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse History of problems with swallowing tablet or capsule History of sensitivity to heparin or heparin-induced thrombocytopenia Any condition possibly affecting drug absorption Have renal creatinine clearance (Clcr) < 45 mL/min based on serum creatinine results at the screening laboratory test 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test: Gemigliptin/Metformin<br>Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) | Drug: Gemigliptin tartrate sesquihydrate and metformin<br>* Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.<br>* Other names: Zemimet® SR Tab. 50/1000 mg;|
| Active Comparator: Reference: Gemigliptin and Metformin<br>Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) | Drug: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release<br>* 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).<br>* Other names: Zemiglo Tablet 50 mg and Glucophage XR 1000 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 (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 | 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 |