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Clinical Trials/NCT02288338
NCT02288338CompletedPhase 1

CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration

Chong Kun Dang Pharmaceutical1 site in 1 country36 target enrollmentStarted: November 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
AUCτ,ss of atorvastatin and free ezetimibe
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A randomized open-label, multiple dose, three-treatment, three-period, six-sequence, crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and Ezetimibe after oral administration in healthy volunteers

Detailed Description

Outcome Measures

  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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age Eligible for Study : 19 Years to 45 Years
  • •If males, Body weight ≥ 55kg, If females, Body weight ≥ 50kg
  • •BSA ≥ 18.5, <25
  • •Accepts healthy volunteers
  • •If female, Negative for pregnancy test at the screening and pre dose of Day 1
  • •The subjects who agree with performing contraception during the study
  • •The subjects who agreed with written informed consent

Exclusion Criteria

  • •The subjects with impaired hepatic function, renal function, nervous system etc.
  • •The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
  • •The subjects with high blood pressure or low blood pressure (Systolic blood pressure>150mmHg or <90mmHg, Diastolic blood pressure>100mmHg or <50mmHg
  • •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
  • •The subjects have drug abuse history within 1year or Positive for urine drug test at screening
  • •The subjects who took prescription only medicine whch can be effected in metabolism of Investigational product within 14days
  • •The subjects who took over the counter drug whch can be effected in metabolism of Investigational product within 7days

Arms & Interventions

1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®)

Experimental

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

Intervention: 1 (Lipitor®) (Drug)

1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®)

Experimental

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

Intervention: 1 (Ezetrol®) (Drug)

1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®)

Experimental

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

Intervention: 1 (Lipitor®, Ezetrol®) (Drug)

2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®)

Experimental

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

Intervention: 2 (Ezetrol®) (Drug)

2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®)

Experimental

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

Intervention: 2(Lipitor®, Ezetrol®) (Drug)

2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®)

Experimental

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

Intervention: 2 (Lipitor®) (Drug)

3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®)

Experimental

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

Intervention: 3(Lipitor®, Ezetrol®) (Drug)

3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®)

Experimental

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

Intervention: 3 (Lipitor®) (Drug)

3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®)

Experimental

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

Intervention: 3 (Ezetrol®) (Drug)

4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®)

Experimental
  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

Intervention: 4 (Lipitor®) (Drug)

4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®)

Experimental
  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

Intervention: 4(Lipitor®, Ezetrol®) (Drug)

4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®)

Experimental
  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

Intervention: 4 (Ezetrol®) (Drug)

5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®)

Experimental
  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

Intervention: 5 (Ezetrol®) (Drug)

5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®)

Experimental
  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

Intervention: 5 (Lipitor®) (Drug)

5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®)

Experimental
  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

Intervention: 5 (Lipitor®, Ezetrol®) (Drug)

6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®)

Experimental
  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

Intervention: 6(Lipitor®, Ezetrol®) (Drug)

6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®)

Experimental
  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

Intervention: 6 (Ezetrol®) (Drug)

6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®)

Experimental
  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

Intervention: 6 (Lipitor®) (Drug)

Outcomes

Primary Outcomes

AUCτ,ss of atorvastatin and free ezetimibe

Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)

Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h

Cmax,ss of atorvastatin and free ezetimibe

Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)

Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h

Secondary Outcomes

  • %fluctuation of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • AUCτ,ss of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • tmax,ss of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • CL/Fss of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • Vd/Fss of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • AUCinf,ss of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • t1/2 of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • AUCinf,ss of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • Cavg,ss of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • t1/2 of atorvastatin and free ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • Cmax,ss of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • tmax,ss of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))
  • metabolic ratio of 2-hydroxy atorvastatin and total ezetimibe(common : just before the IP administration of D5(D22, D39), D6(D23, D40))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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