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

Dong-A ST Co., Ltd.36 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Type2 Diabetes

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

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.

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUCτ,ss for Evogliptin and Glimepiride

area under the concentration-time curve

Time frame: 3 weeks

Data from ClinicalTrials.gov

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