A Clinical Trial to Investigate Safety/Tolerability and P... | NCT02375139

Official Title

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

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-1229_01 → E+M	Experimental	DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg	Drug: DA-1229_01 Drug: E+M
E+M → DA-1229_01	Experimental	DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg	Drug: DA-1229_01 Drug: E+M

Name	Type	Description	Arm Group Labels	Other Names
DA-1229_01	Drug	complex single administration	DA-1229_01 → E+M E+M → DA-1229_01

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Time of maximum concentration(Tmax) 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
Terminal half-life(t1/2) 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

Eligibility Module

Contacts/Locations Module

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases