A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State

Study Overview
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Brief Summary
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A study demonstrates the bioequivalence of DA-1229_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults

Official Title
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Randomized, Open Label, Single Oral Administration at Fed State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®
* Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients over 19 years of age at the time of health examination Female patients who were confirmed to be not pregnant at health examination Patients without a history of mental illness in the past 5 years Exclusion Criteria: Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial Patients with a congestive heart failure which requires medicinal treatment Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial Female patients who are lactating

Ages Eligible for Study
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Minimum Age: 19 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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test drug, Reference drug group<br>Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. | Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®<br>* Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.<br>* Other names: Test drug, Reference drug group;|
| Active Comparator: Reference drug,Test drug group<br>Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. | Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)<br>* Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.<br>* Other names: Reference drug,Test drug group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve(AUCt) | AUCt of metformin | Hour -1   Hour 24 | 
| Maximum plasmaconcentration of drug in plasma(Cmax) | Cmax of metformin | Hour -1   Hour 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf) | AUCinf of metformin | Hour -1   Hour 24 | 
| AUCt/AUCinf | AUCt/AUCinf of metformin | Hour -1   Hour 24 | 
| Time to reach the maximum plasma concentration(Tmax) | Tmax of metformin | Hour -1   Hour 24 | 
| Terminal elimination rate constant(ramda z) | ramda z of metformin | Hour -1   Hour 24 | 
| Terminal elimination half-life(t1/2) | t1/2 of metformin | Hour -1   Hour 24 |