A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State
NCT ID: NCT03944200
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2019-02-07
2019-03-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
NCT06290349
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
NCT02060201
Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
NCT02223065
A Study of RAY1225 in Participants With Type 2 Diabetes
NCT06254274
A Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers Under Fed Conditions
NCT06890299
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 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.
DA-1229_01(A), Sugamet SR Tab 5/1000mg®
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.
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 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.
Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DA-1229_01(A), Sugamet SR Tab 5/1000mg®
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.
Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sung Dae Kwon, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Metro Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Metro Hospital
Anyang-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DDS18-034BE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.