A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
NCT ID: NCT04703374
Last Updated: 2021-01-11
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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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2020-09-25
2021-09-30
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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A
Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
B
Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
C
Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
D
Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
E
Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
F
Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)
CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
Interventions
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CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
D026
1 tablet administered under fasting condition for 7days
Eligibility Criteria
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Inclusion Criteria
2. Body weight more than 50kg
3. Body Mass Index more than 18.0 and under 27.0
4. Who has negative result on Helicobacter Pylori antibody test
Exclusion Criteria
2. Have a gastrointestinal disease history(including surgery) that can effect drug absorption
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, 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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Locations
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Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A105_01BE2010
Identifier Type: -
Identifier Source: org_study_id
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