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Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

NCT02954822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-09-18

No results posted yet for this study

Summary

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Conditions

  • Type2 Diabetes

Interventions

DRUG

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days. Glimepiride : Glimepiride 4mg QD Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

DRUG

Glimepiride→Evogliptin→Evogliptin+Glimepiride

After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D., Ph.D. · Clinical Trial Center, Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2017-01-25
Completion
2017-08-09

Countries

  • South Korea

Study Locations

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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 NCT02954822 on ClinicalTrials.gov