A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State
NCT ID: NCT03939143
Last Updated: 2020-05-20
Study Results
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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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2019-02-07
2019-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
Yes
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sung Dae Kwon, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Metro Hospital
Locations
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Metro Hospital
Anyang-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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DDS18-033BE
Identifier Type: -
Identifier Source: org_study_id
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