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
NCT02375139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2015-07-22
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
Interventions
- DRUG
-
DA-1229_01
complex single administration
- DRUG
-
E+M
co-administration of 2 drugs
Sponsors & Collaborators
-
Dong-A ST Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyung-sang Yu, Ph.D, M.B.A · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- South Korea
Study Locations
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