A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers
NCT ID: NCT04830930
Last Updated: 2021-08-18
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
28 participants
INTERVENTIONAL
2021-04-21
2021-07-26
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: fasted condition/ Period 2: fed condition
CKD-381
single-dose, oral administration of CKD-381 1 tablet
Sequence 2
Period 1: fed condition/ Period 2: fasted condition
CKD-381
single-dose, oral administration of CKD-381 1 tablet
Interventions
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CKD-381
single-dose, oral administration of CKD-381 1 tablet
Eligibility Criteria
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Inclusion Criteria
2. Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
3. Have negative result on Helicobacter Pylori antibody test
Exclusion Criteria
2. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
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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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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A73_04FDI2102
Identifier Type: -
Identifier Source: org_study_id
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