Pharmacokinetics and Safety/Tolerability Profile of CKD-379
NCT ID: NCT05452525
Last Updated: 2022-10-18
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
24 participants
INTERVENTIONAL
2022-07-26
2022-09-21
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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Sequence 1
Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Sequence 2
Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Sequence 3
Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Sequence 4
Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Sequence 5
Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Sequence 6
Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)
CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Interventions
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CKD-379 I
1 tablet administration under fed condition
CKD-379 II
1 tablet administration under fed condition
D759+D745+D150
3 tablet coadministration under fed condition
Eligibility Criteria
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Inclusion Criteria
* 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2
Exclusion Criteria
* Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
* Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators
19 Years
50 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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Jaeseong Oh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Countries
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Other Identifiers
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A125_01BE2204
Identifier Type: -
Identifier Source: org_study_id
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