A Phase 1 interventional study of DA-1229_01(A), Sugamet SR Tab 5/1000mg® and Sugamet SR Tab 5/1000mg®, DA-1229_01(A) in Type2 Diabetes, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Health services research
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
Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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®
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)
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.
Also known as: Test drug, Reference drug group
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.
Also known as: Reference drug,Test drug group
Area under the concentration-time curve(AUCt)
AUCt of metformin
Time frame: Hour -1 ~ Hour 24
Maximum plasmaconcentration of drug in plasma(Cmax)
Cmax of metformin
Time frame: Hour -1 ~ Hour 24
Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)
AUCinf of metformin
Time frame: Hour -1 ~ Hour 24
AUCt/AUCinf
AUCt/AUCinf of metformin
Time frame: Hour -1 ~ Hour 24
Time to reach the maximum plasma concentration(Tmax)
Tmax of metformin
Time frame: Hour -1 ~ Hour 24
Terminal elimination rate constant(ramda z)
ramda z of metformin
Time frame: Hour -1 ~ Hour 24
Terminal elimination half-life(t1/2)
t1/2 of metformin
Time frame: Hour -1 ~ Hour 24
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Dong-A ST Co., Ltd.