A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
NCT ID: NCT04690868
Last Updated: 2022-04-27
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
43 participants
INTERVENTIONAL
2021-10-15
2021-12-21
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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ARM 1
Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A)
AD-213-A
1 tablet administered before the breakfast during 5 days
AD-2131
1 tablet administered before the breakfast during 5 days
ARM 2
Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131)
AD-213-A
1 tablet administered before the breakfast during 5 days
AD-2131
1 tablet administered before the breakfast during 5 days
Interventions
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AD-213-A
1 tablet administered before the breakfast during 5 days
AD-2131
1 tablet administered before the breakfast during 5 days
Eligibility Criteria
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Inclusion Criteria
* Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
Exclusion Criteria
* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
* Subjects who judged ineligible by the investigator.
19 Years
ALL
Yes
Sponsors
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Addpharma Inc.
INDUSTRY
Responsible Party
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Locations
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Kyungpook National University Hospital
Daegu, , South Korea
Countries
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Other Identifiers
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AD-213PK/PD
Identifier Type: -
Identifier Source: org_study_id
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