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

A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02954822

Enrollment

Registered

2016-11-03

Start date

2016-11-14

Completion date

2017-08-09

Last updated

2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

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

Detailed description

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

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
AUCτ,ss for Evogliptin and Glimepiride	3 weeks	area under the concentration-time curve

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026