Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Dong-A ST Co., Ltd.36 enrolled

Overview

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Evogliptin, Pioglitazone, Evogliptin+PioglitazoneDRUG

Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

Pioglitazone, Evogliptin, Evogliptin+PioglitazoneDRUG

Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

Evogliptin, Evogliptin+Pioglitazone, PioglitazoneDRUG

Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD

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

AUC

area under the concentration-time curve

Time frame: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose

Data from ClinicalTrials.gov

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