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
44 participants
INTERVENTIONAL
2019-10-30
2020-01-09
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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Group A
R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T
CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
D090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Group B
R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T
CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
D090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Group C
T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R
CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
D090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Group D
T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R
CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
D090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Interventions
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CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
D090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
3. Not abnormal or not clinically significant lab values.
4. Subjects who signed informed consent form with good understandings after explanations by investigators.
Exclusion Criteria
2. Subjects showing adverse reaction to investigational product
3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
4. History of myopathy
5. unable to stop drinking and smoking during clinical trials
6. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
7. History of drug abuse
8. Disagree to contraception
9. Subjects who are in any conditions impossible participating in the clinical trials
19 Years
45 Years
MALE
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Jae-Yong Chung
Gyeonggi-do, Seongnam-si, South Korea
Countries
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Other Identifiers
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152BE18037
Identifier Type: -
Identifier Source: org_study_id
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