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
52 participants
INTERVENTIONAL
2015-07-31
2015-10-31
Brief Summary
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Detailed Description
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Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
CKD-391
Investigational product is prescribed to all of radomized subjects for two times.
Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.
RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
CKD-391
Investigational product is prescribed to all of radomized subjects for two times.
Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.
Interventions
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CKD-391
Investigational product is prescribed to all of radomized subjects for two times.
Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.
Eligibility Criteria
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Inclusion Criteria
* signed the informed consent form prior to the study participation
Exclusion Criteria
* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Clinically significant allergic disease
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
19 Years
45 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Ji Young Park, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Korea University Anam Hospital
Locations
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The Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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152BE15016
Identifier Type: -
Identifier Source: org_study_id
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