NCT02375139

A 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 in Healthy Male Volunteers

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DA-1229_01	complex single administration
DRUG	E+M	co-administration of 2 drugs

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-03-02
• Last updated: 2015-07-22

Locations

1 site across 1 country: South Korea