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Completed

NCT Number: NCT02288338

CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ChongKunDang

Seoul, South Korea

About this study

Outcome Measures

  • Primary endpoint AUCτ,ss, Cmax,ss of atorvastatin and free ezetimibe
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 (Lipitor®)

Drug

atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

1 (Ezetrol®)

Drug

After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

1 (Lipitor®, Ezetrol®)

Drug

After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

2 (Ezetrol®)

Drug

ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

2(Lipitor®, Ezetrol®)

Drug

After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

2 (Lipitor®)

Drug

After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

3(Lipitor®, Ezetrol®)

Drug

atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

3 (Lipitor®)

Drug

After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

3 (Ezetrol®)

Drug

After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

4 (Lipitor®)

Drug

atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

4(Lipitor®, Ezetrol®)

Drug

After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

4 (Ezetrol®)

Drug

After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

5 (Ezetrol®)

Drug

ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

5 (Lipitor®)

Drug

After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

5 (Lipitor®, Ezetrol®)

Drug

After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

6(Lipitor®, Ezetrol®)

Drug

atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg, Ezetrol® 10mg

6 (Ezetrol®)

Drug

After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days

Other names: Ezetrol® 10mg

6 (Lipitor®)

Drug

After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days

Other names: Lipitor® 40mg

Primary outcomes

  1. 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

  2. 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

  1. AUCinf,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

  2. Cavg,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

  3. %fluctuation 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

  4. tmax,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

  5. t1/2 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

  6. CL/Fss 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

  7. Vd/Fss 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

  8. AUCτ,ss of 2-hydroxy atorvastatin and total 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

  9. AUCinf,ss of 2-hydroxy atorvastatin and total 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

  10. Cmax,ss of 2-hydroxy atorvastatin and total 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

  11. tmax,ss of 2-hydroxy atorvastatin and total 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

  12. t1/2 of 2-hydroxy atorvastatin and total 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

  13. metabolic ratio of 2-hydroxy atorvastatin and total 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2014
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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