Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
NCT ID: NCT03793985
Last Updated: 2019-01-07
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
45 participants
INTERVENTIONAL
2018-09-05
2018-11-13
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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A (R+T+R+T)
Period 1 : R Period 2 : T Period 3 : R Period 4 : T
T
CKD-391 40/10mg
R
D086 and D337 co-administration
B (T+R+T+R)
Period 1 : T Period 2 : R Period 3 : T Period 4 : R
T
CKD-391 40/10mg
R
D086 and D337 co-administration
Interventions
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T
CKD-391 40/10mg
R
D086 and D337 co-administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Over 50 kg, BMI between 18.0-29.0 kg/m2
3. 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.
4. Not abnormal or not clinically significant lab values.
5. 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. Subjects with abnormal lab values at least one below 1) AST or ALT\>2 fold of upper normal limit 2) Total bilirubin\>2 fold of upper normal limit 3) CK\>2 fold of upper normal limit 4) Estimated Glomerular filtration rate\<60mL/min/1.73m2
6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
7. Smoke over 10 cigarettes per day or unable to stop smoking
8. Subjects who previously participated in other clinical trials within 90 days
9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
11. Taking medications which induce or block medication metabolism
12. History of drug abuse
13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
14. Disagree to contraception
15. Subjects who are in any conditions impossible participating in the clinical trials
19 Years
45 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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INHA University Hospital
Incheon, , South Korea
Countries
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Other Identifiers
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152BE17006
Identifier Type: -
Identifier Source: org_study_id
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