CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

Chong Kun Dang Pharmaceutical36 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

1 (Lipitor®)DRUG

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

1 (Ezetrol®)DRUG

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

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age Eligible for Study : 19 Years to 45 Years 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: 1. The subjects with impaired hepatic function, renal function, nervous system etc. 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

Locations (1)

ChongKunDang

Seoul, South Korea

Outcomes

Primary Outcomes

AUCτ,ss of atorvastatin and free ezetimibe

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

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

Cmax,ss of atorvastatin and free ezetimibe

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

Secondary Outcomes

AUCinf,ss of atorvastatin and free ezetimibe

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

Cavg,ss of atorvastatin and free ezetimibe

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

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

2 (Lipitor®)DRUG

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

3(Lipitor®, Ezetrol®)DRUG

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

3 (Lipitor®)DRUG

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

3 (Ezetrol®)DRUG

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

4 (Lipitor®)DRUG

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

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

4 (Ezetrol®)DRUG

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

5 (Ezetrol®)DRUG

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

5 (Lipitor®)DRUG

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

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

6(Lipitor®, Ezetrol®)DRUG

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

6 (Ezetrol®)DRUG

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

6 (Lipitor®)DRUG

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

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

%fluctuation of atorvastatin and free ezetimibe

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

tmax,ss of atorvastatin and free ezetimibe

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

t1/2 of atorvastatin and free ezetimibe

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

CL/Fss of atorvastatin and free ezetimibe

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

Vd/Fss of atorvastatin and free ezetimibe

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

AUCτ,ss of 2-hydroxy atorvastatin and total ezetimibe

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

AUCinf,ss of 2-hydroxy atorvastatin and total ezetimibe

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

Cmax,ss of 2-hydroxy atorvastatin and total ezetimibe

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

tmax,ss of 2-hydroxy atorvastatin and total ezetimibe

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

t1/2 of 2-hydroxy atorvastatin and total ezetimibe

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

metabolic ratio of 2-hydroxy atorvastatin and total ezetimibe

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