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

September 15, 2017 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Clinical trials center, Seoul national university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group
Evogliptin Pioglitazone Evogliptin+Pioglitazone
Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone
Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
Other Names:
  • Actos
  • Suganon
Experimental: B group
Pioglitazone Evogliptin Evogliptin+Pioglitazone
Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone
Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
Other Names:
  • Actos
  • Suganon
Experimental: C group
Evogliptin Evogliptin+Pioglitazone Pioglitazone
Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone
Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD
Other Names:
  • Actos
  • Suganon
Experimental: D group
Pioglitazone Evogliptin+Pioglitazone Evogliptin
Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin
Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
Other Names:
  • Actos
  • Suganon
Experimental: E group
Evogliptin+Pioglitazone Evogliptin Pioglitazone
Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone
Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD
Other Names:
  • Actos
  • Suganon
Experimental: F group
Evogliptin+Pioglitazone Pioglitazone Evogliptin
Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin
Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
Other Names:
  • Actos
  • Suganon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 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
1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Kyung-Sang Yu, M.D., Ph.D., Clinical trials center, Seoul national university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2016

Primary Completion (Actual)

October 19, 2016

Study Completion (Actual)

March 10, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_DIP_I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Evogliptin, Pioglitazone, Evogliptin+Pioglitazone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe