A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State

May 18, 2020 updated by: Dong-A ST Co., Ltd.

Randomized, Open Label, Single Oral Administration at Fasting State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)

A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 14096
        • Metro 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients over 19 years of age at the time of health examination
  • Female patients who were confirmed to be not pregnant at health examination
  • Patients without a history of mental illness in the past 5 years

Exclusion Criteria:

  • Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
  • Patients with a congestive heart failure which requires medicinal treatment
  • Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
  • Female patients who are lactating

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test drug, Reference drug group

Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.

The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®

Period 1: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.

Other Names:
  • Test drug, Reference drug group
ACTIVE_COMPARATOR: Reference drug,Test drug group

Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.

The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.
Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)

Period 1: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.

The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.

Other Names:
  • Reference drug,Test drug group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve(AUCt)
Time Frame: Hour -1 ~ Hour 72
AUCt of evogliptin and metformin
Hour -1 ~ Hour 72
Maximum plasmaconcentration of drug in plasma(Cmax)
Time Frame: Hour -1 ~ Hour 72
Cmax of evogliptin and metformin
Hour -1 ~ Hour 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)
Time Frame: Hour -1 ~ Hour 72
AUCinf of evogliptin and metformin
Hour -1 ~ Hour 72
AUCt/AUCinf
Time Frame: Hour -1 ~ Hour 72
AUCt/AUCinf of evogliptin and metformin
Hour -1 ~ Hour 72
Time to reach the maximum plasma concentration(Tmax)
Time Frame: Hour -1 ~ Hour 72
Tmax of evogliptin and metformin
Hour -1 ~ Hour 72
Terminal elimination rate constant(ramda z)
Time Frame: Hour -1 ~ Hour 72
ramda z of evogliptin and metformin
Hour -1 ~ Hour 72
Terminal elimination half-life(t1/2)
Time Frame: Hour -1 ~ Hour 72
t1/2 of evogliptin and metformin
Hour -1 ~ Hour 72

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: Sung Dae Kwon, M.D., Ph.D., Metro 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)

February 7, 2019

Primary Completion (ACTUAL)

April 4, 2019

Study Completion (ACTUAL)

April 4, 2019

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DDS18-033BE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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