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Completed

NCT Number: NCT03944200

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

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

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Key information

Conditions

Type2 Diabetes

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Metro Hospital

Anyang-si, Gyeonggi-do, 14096, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-1229_01(A), Sugamet SR Tab 5/1000mg®

Drug

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 fed study is 7 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.

Other names: Test drug, Reference drug group

Sugamet SR Tab 5/1000mg®, DA-1229_01(A)

Drug

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 fed study is 7 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.

Other names: Reference drug,Test drug group

Primary outcomes

  1. Area under the concentration-time curve(AUCt)

    Time frame: Hour -1 ~ Hour 24

    AUCt of metformin

  2. Maximum plasmaconcentration of drug in plasma(Cmax)

    Time frame: Hour -1 ~ Hour 24

    Cmax of metformin

Secondary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)

    Time frame: Hour -1 ~ Hour 24

    AUCinf of metformin

  2. AUCt/AUCinf

    Time frame: Hour -1 ~ Hour 24

    AUCt/AUCinf of metformin

  3. Time to reach the maximum plasma concentration(Tmax)

    Time frame: Hour -1 ~ Hour 24

    Tmax of metformin

  4. Terminal elimination rate constant(ramda z)

    Time frame: Hour -1 ~ Hour 24

    ramda z of metformin

  5. Terminal elimination half-life(t1/2)

    Time frame: Hour -1 ~ Hour 24

    t1/2 of metformin

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 9, 2019
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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