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CompletedNCT02954822Updated Sep 18, 2017

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

A Phase 1 interventional study of Evogliptin→Evogliptin+Glimepiride→Glimepiride and Glimepiride→Evogliptin→Evogliptin+Glimepiride in Type2 Diabetes, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

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

Read the detailed description

A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

02

Conditions studied

  • Type2 Diabetes
03

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Male Volunteers (Age: 19\~45years)
  • 55\<Body Weight\<90, 18\<BMI\<27
  • FPG: 70-125 mg/dL

Exclusion criteria

Exclusion Criteria:

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Clinically significant Medical History
  • Allergy or Drug Hypersensitivity
  • AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR\<80 mL/min
  • Drink during clinical trial period
  • Smoking during clinical trial period
  • Grapefruit/Caffeine intake during clinical trial period
  • No Contraception
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    (Group A)

    Evogliptin→Evogliptin+Glimepiride→Glimepiride

    Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride

  • Experimental
    (Group B)

    Glimepiride→Evogliptin→Evogliptin+Glimepiride

    Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride

Interventions

  • DrugEvogliptin→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

    Also known as: Suganon, Amaryl

  • DrugGlimepiride→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.

    Also known as: Suganon, Amaryl

06

What researchers measure

Primary outcomes

  1. AUCτ,ss for Evogliptin and Glimepiride

    area under the concentration-time curve

    Time frame: 3 weeks

07

Study locations

1 site
  • Clinical Trials Center, Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02954822
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Nov 3, 2016
Start date
Nov 14, 2016
Primary completion
Jan 25, 2017
Completion
Aug 9, 2017
Last update
Sep 18, 2017

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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