CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
NCT ID: NCT02288338
Last Updated: 2015-03-10
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
36 participants
INTERVENTIONAL
2014-11-30
2015-02-28
Brief Summary
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Detailed Description
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1. Primary endpoint AUCτ,ss, Cmax,ss of atorvastatin and free ezetimibe
2. Second endpoint 1) AUCinf,ss, Cavg,ss, %fluctuation, tmax,ss, t1/2, CL/Fss, Vd/Fss of atorvastatin and free ezetimibe 2) AUCτ,ss, AUCinf,ss, Cmax,ss, tmax,ss, t1/2, metabolic ratio of 2-hydroxy atorvastatin and free ezetimibe
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®)
Three treatment
1. atorvastatin calcium 40mg will be administration to healthy volunteers during 7days
2. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
1 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
1 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
1 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®)
Three treatment
1. ezetimibe 10mg will be administered to healthy volunteers during 7days
2. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
2 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®)
Three treatment
1. atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
2. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
3(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
3 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®)
1. atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
2. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
4 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
4(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
4 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®)
1. ezetimibe 10mg will be administered to healthy volunteers during 7days
2. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
5 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
5 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®)
1. atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
2. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
3. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
6(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Interventions
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1 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
1 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
1 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
3 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
4 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
4(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
4 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
5 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. If males, Body weight ≥ 55kg, If females, Body weight ≥ 50kg
3. BSA ≥ 18.5, \<25
4. Accepts healthy volunteers
5. If female, Negative for pregnancy test at the screening and pre dose of Day 1
6. The subjects who agree with performing contraception during the study
7. The subjects who agreed with written informed consent
Exclusion Criteria
2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
3. The subjects with high blood pressure or low blood pressure (Systolic blood pressure\>150mmHg or \<90mmHg, Diastolic blood pressure\>100mmHg or \<50mmHg
4. The subjects with abnormal Laboratory test (AST, ALT\>1.25 fold of upper normal limit, Total bilirubin\>1.5 fold of upper normal limit, CPK\>2 fold of upper normal limit, Estimated Glomerular filtration rate\<60mL/min/1.73m2 by Modification of Diet in Renal disease formula
5. The subjects have drug abuse history within 1year or Positive for urine drug test at screening
6. The subjects who took prescription only medicine whch can be effected in metabolism of Investigational product within 14days
7. The subjects who took over the counter drug whch can be effected in metabolism of Investigational product within 7days
19 Years
45 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Min Soo Park, Ph.D. M.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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ChongKunDang
Seoul, , South Korea
Countries
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Other Identifiers
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152DDI14016
Identifier Type: -
Identifier Source: org_study_id
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