A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
NCT ID: NCT03980756
Last Updated: 2021-01-13
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
88 participants
INTERVENTIONAL
2019-06-05
2020-06-18
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 A1
Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
AD-206 20mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 20mg
1 tablet administered before the breakfast during 7 days
Group A2
Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
AD-206 20mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 20mg
1 tablet administered before the breakfast during 7 days
Group B1
Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
AD-206 40mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 40mg
1 tablet administered before the breakfast during 7 days
Group B2
Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)
AD-206 40mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 40mg
1 tablet administered before the breakfast during 7 days
Interventions
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AD-206 20mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 20mg
1 tablet administered before the breakfast during 7 days
AD-206 40mg
1 tablet administered before the breakfast during 7 days
Esomeprazole 40mg
1 tablet administered before the breakfast during 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria
* Subjects who judged ineligible by the investigator
19 Years
50 Years
MALE
Yes
Sponsors
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Addpharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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In-Jin Jang, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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AD-206PK/PD
Identifier Type: -
Identifier Source: org_study_id
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