A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects
NCT ID: NCT03444402
Last Updated: 2018-05-24
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
18 participants
INTERVENTIONAL
2018-03-02
2018-05-04
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
TREATMENT
NONE
Study Groups
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Group A
Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
CKD-381(formulation I)
1 tablet administered before the breakfast during 7 days
CKD-381(formulation II)
1 tablet administered before the breakfast during 7 days
D026(Nexium 40mg)
1 tablet administered before the breakfast during 7 days
Group B
Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
CKD-381(formulation I)
1 tablet administered before the breakfast during 7 days
CKD-381(formulation II)
1 tablet administered before the breakfast during 7 days
D026(Nexium 40mg)
1 tablet administered before the breakfast during 7 days
Group C
Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
CKD-381(formulation I)
1 tablet administered before the breakfast during 7 days
CKD-381(formulation II)
1 tablet administered before the breakfast during 7 days
D026(Nexium 40mg)
1 tablet administered before the breakfast during 7 days
Interventions
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CKD-381(formulation I)
1 tablet administered before the breakfast during 7 days
CKD-381(formulation II)
1 tablet administered before the breakfast during 7 days
D026(Nexium 40mg)
1 tablet administered before the breakfast during 7 days
Eligibility Criteria
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Inclusion Criteria
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25
Exclusion Criteria
2. Have a gastrointestinal disease history that can effect drug absorption or surgery.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.
19 Years
50 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung Sang Yu, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital
Locations
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Seoul University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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173HPS17013
Identifier Type: -
Identifier Source: org_study_id
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