A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers
NCT ID: NCT02166398
Last Updated: 2015-06-12
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
46 participants
INTERVENTIONAL
2014-06-30
2014-12-31
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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Amosartan 5/50 tab
Amosartan 5/50 tab given by oral administration
Amosartan 5/50
tab, PO
UI15AML055MT tab
UI15AML055MT tab given by oral administration
UI15AML055MT
tab, PO
Interventions
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UI15AML055MT
tab, PO
Amosartan 5/50
tab, PO
Eligibility Criteria
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Inclusion Criteria
* BMI state over 19 under 27
Exclusion Criteria
* mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
20 Years
45 Years
MALE
Yes
Sponsors
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Korea United Pharm. Inc.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Countries
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Other Identifiers
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KUP-UNSD-101
Identifier Type: -
Identifier Source: org_study_id
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