NCT02954822

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

November 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

November 2, 2016

Last Update Submit

September 15, 2017

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • AUCτ,ss for Evogliptin and Glimepiride

    area under the concentration-time curve

    3 weeks

Study Arms (2)

(Group A)

EXPERIMENTAL

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride

(Group B)

EXPERIMENTAL

Glimepiride→Evogliptin→Evogliptin+Glimepiride

Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride

Interventions

Evogliptin→Evogliptin+Glimepiride→GlimepirideDRUG

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
(Group A)
Glimepiride→Evogliptin→Evogliptin+GlimepirideDRUG

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
(Group B)

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

glimepiride

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Clinical Trial Center, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 3, 2016

Study Start

November 14, 2016

Primary Completion

January 25, 2017

Study Completion

August 9, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

KR(1)