A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
NCT ID: NCT04494243
Last Updated: 2021-07-21
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
40 participants
INTERVENTIONAL
2020-08-28
2021-01-15
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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AD-214/Rabeprazole
Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)
AD-214 10/600mg
1 tablet administered before the breakfast during 7 days
Rabeprazole 10mg
1 tablet administered before the breakfast during 7 days
Rabeprazole/AD-214
Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)
AD-214 10/600mg
1 tablet administered before the breakfast during 7 days
Rabeprazole 10mg
1 tablet administered before the breakfast during 7 days
Interventions
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AD-214 10/600mg
1 tablet administered before the breakfast during 7 days
Rabeprazole 10mg
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 18.0 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
ALL
Yes
Sponsors
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Addpharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Seunghwan Lee, 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-214PK/PD
Identifier Type: -
Identifier Source: org_study_id
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