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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 7, 2019

Primary Completion Date

March 25, 2019

Study Completion Date

March 25, 2019

Conditions
Type2 Diabetes
Interventions
DRUG

DA-1229_01(A), Sugamet SR Tab 5/1000mg®

"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

Sugamet SR Tab 5/1000mg®, DA-1229_01(A)

"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."

Trial Locations (1)

14096

Metro Hospital, Anyang-si

All Listed Sponsors
lead

Dong-A ST Co., Ltd.

INDUSTRY

NCT03944200 - A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State | Biotech Hunter | Biotech Hunter