Who is sponsoring NCT02375139?

NCT02375139 is sponsored by Dong-A ST Co., Ltd..

What condition does NCT02375139 study?

NCT02375139 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT02375139?

Interventions: DA-1229_01, E+M.

What is the status of NCT02375139?

NCT02375139 is currently COMPLETED.

Last reviewed 2015-07-21 · How we verify

A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 (Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg After Single Oral Administration in Healthy Male Volunteers

NCT02375139 Phase 1 COMPLETED

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).

Details

Lead sponsor	Dong-A ST Co., Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2015-04
Completion	2015-06

Conditions

Type 2 Diabetes Mellitus

Interventions

DA-1229_01
E+M

Primary outcomes

Area Under Curve(AUC)last of Evogliptin and Metformin — 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Maximum of concentration (Cmax) of Evogliptin and Metformin — 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Countries

South Korea