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

NCT ID: NCT02753803

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2017-03-10

Brief Summary

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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

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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A group

Evogliptin Pioglitazone Evogliptin+Pioglitazone

Group Type EXPERIMENTAL

Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

Intervention Type DRUG

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

B group

Pioglitazone Evogliptin Evogliptin+Pioglitazone

Group Type EXPERIMENTAL

Pioglitazone, Evogliptin, Evogliptin+Pioglitazone

Intervention Type DRUG

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

C group

Evogliptin Evogliptin+Pioglitazone Pioglitazone

Group Type EXPERIMENTAL

Evogliptin, Evogliptin+Pioglitazone, Pioglitazone

Intervention Type DRUG

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

D group

Pioglitazone Evogliptin+Pioglitazone Evogliptin

Group Type EXPERIMENTAL

Pioglitazone, Evogliptin+Pioglitazone, Evogliptin

Intervention Type DRUG

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

E group

Evogliptin+Pioglitazone Evogliptin Pioglitazone

Group Type EXPERIMENTAL

Evogliptin+Pioglitazone, Evogliptin, Pioglitazone

Intervention Type DRUG

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

F group

Evogliptin+Pioglitazone Pioglitazone Evogliptin

Group Type EXPERIMENTAL

Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

Intervention Type DRUG

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

Interventions

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Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

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

Intervention Type DRUG

Pioglitazone, Evogliptin, Evogliptin+Pioglitazone

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

Intervention Type DRUG

Evogliptin, Evogliptin+Pioglitazone, Pioglitazone

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

Intervention Type DRUG

Pioglitazone, Evogliptin+Pioglitazone, Evogliptin

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

Intervention Type DRUG

Evogliptin+Pioglitazone, Evogliptin, Pioglitazone

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

Intervention Type DRUG

Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

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

Intervention Type DRUG

Other Intervention Names

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Suganon Actos Suganon Actos Suganon Actos Suganon Actos Suganon Actos Suganon Actos

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Trials Center, Seoul National University Hospital

Locations

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Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_DIP_I

Identifier Type: -

Identifier Source: org_study_id