A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
NCT ID: NCT06204107
Last Updated: 2024-01-12
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
28 participants
INTERVENTIONAL
2023-11-21
2023-12-06
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
TREATMENT
NONE
Study Groups
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Group 1
* Phase 1: CKD-379 Test drug
* Phase 2: CKD-379 Reference drug
CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once
Group 2
* Phase 1: CKD-379 Reference drug
* Phase 2: CKD-379 Test drug
CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once
Interventions
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CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once
Eligibility Criteria
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Inclusion Criteria
* BMI measurement result is 18.0 kg/m2 to 30 kg/m2
* Written informed consent
Exclusion Criteria
* AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
* History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
* Participated in a clinical trial within 6 months prior to 1st IP dosing
19 Years
54 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Jaeyong Jeong
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam, , South Korea
Countries
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Other Identifiers
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A125_05FDI2310
Identifier Type: -
Identifier Source: org_study_id
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