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A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

NCT02167061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-12-02

No results posted yet for this study

Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\_01 in healthy male volunteers

Conditions

Interventions

DRUG

DA-1229_01

complex single administration

DRUG

E+M

co-administration of 2 drugs

DRUG

DA-1229_01 fast

DRUG

DA-1229_01 fed

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
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167061 on ClinicalTrials.gov