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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03939143

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Type2 Diabetes
  • Intervention/Treatment: Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®
    Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 34 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Health Services Research
  • Official Title: Randomized, Open Label, Single Oral Administration at Fasting State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: July 2019
Arms and interventions
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Area under the concentration-time curve(AUCt) [ Time Frame: Hour -1 ~ Hour 72 ]
    AUCt of evogliptin and metformin
  • 2. Maximum plasmaconcentration of drug in plasma(Cmax) [ Time Frame: Hour -1 ~ Hour 72 ]
    Cmax of evogliptin and metformin
  • Secondary Outcome Measures: 1. 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
  • 2. AUCt/AUCinf [ Time Frame: Hour -1 ~ Hour 72 ]
    AUCt/AUCinf of evogliptin and metformin
  • 3. Time to reach the maximum plasma concentration(Tmax) [ Time Frame: Hour -1 ~ Hour 72 ]
    Tmax of evogliptin and metformin
  • 4. Terminal elimination rate constant(ramda z) [ Time Frame: Hour -1 ~ Hour 72 ]
    ramda z of evogliptin and metformin
  • 5. Terminal elimination half-life(t1/2) [ Time Frame: Hour -1 ~ Hour 72 ]
    t1/2 of evogliptin and metformin
Eligibility Criteria
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: Sung Dae Kwon, M.D., Ph.D. 031-467-9927 uro777@nate.com

Locations

Korea, Republic of, Gyeonggi-do
Metro Hospital
Anyang-si

Sponsors and Collaborators

Dong-A ST Co., Ltd.

Investigators

Principal Investigator: Sung Dae Kwon, M.D., Ph.D. Metro Hospital

More Information
  • Responsible Party: Dong-A ST Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03939143 History of Changes
  • Other Study ID Numbers: DDS18-033BE
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No