A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
NCT ID: NCT05128591
Last Updated: 2022-03-08
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
38 participants
INTERVENTIONAL
2021-11-09
2021-12-31
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 A-Rivaroxaban
Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109)
Rivaroxaban 18mg Oral Tablet
AD-109 (Rivaroxaban 18mg) Oral Tablet
Rivaroxaban 20 MG Oral Tablet
AD-1091 (Rivaroxaban 20mg) Oral Tablet
Arm B-Rivaroxaban
Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091
Rivaroxaban 18mg Oral Tablet
AD-109 (Rivaroxaban 18mg) Oral Tablet
Rivaroxaban 20 MG Oral Tablet
AD-1091 (Rivaroxaban 20mg) Oral Tablet
Interventions
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Rivaroxaban 18mg Oral Tablet
AD-109 (Rivaroxaban 18mg) Oral Tablet
Rivaroxaban 20 MG Oral Tablet
AD-1091 (Rivaroxaban 20mg) Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit
Exclusion Criteria
19 Years
MALE
Yes
Sponsors
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Addpharma Inc.
INDUSTRY
Responsible Party
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Locations
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H+ Yangji Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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AD-109BE
Identifier Type: -
Identifier Source: org_study_id
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