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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02753803

Enrollment

Registered

2016-04-28

Start date

2016-07-27

Completion date

2017-03-10

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

Type 2 Diabetes

Brief summary

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

Detailed description

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

Interventions

DRUGEvogliptin, Pioglitazone, Evogliptin+Pioglitazone

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

DRUGPioglitazone, Evogliptin, Evogliptin+Pioglitazone

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

DRUGEvogliptin, Evogliptin+Pioglitazone, Pioglitazone

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

DRUGPioglitazone, Evogliptin+Pioglitazone, Evogliptin

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

DRUGEvogliptin+Pioglitazone, Evogliptin, Pioglitazone

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

DRUGEvogliptin+Pioglitazone, Pioglitazone, Evogliptin

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

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
AUC	1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose	area under the concentration-time curve

Countries

South Korea

Outcome results

None listed

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