CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

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

Conditions

• Healthy

Interventions

DRUG

1 (Lipitor®)

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

DRUG

1 (Ezetrol®)

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

DRUG

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

DRUG

2 (Ezetrol®)

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

DRUG

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

DRUG

2 (Lipitor®)

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

DRUG

3(Lipitor®, Ezetrol®)

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

DRUG

3 (Lipitor®)

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

DRUG

3 (Ezetrol®)

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

DRUG

4 (Lipitor®)

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

DRUG

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

DRUG

4 (Ezetrol®)

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

DRUG

5 (Ezetrol®)

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

DRUG

5 (Lipitor®)

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

DRUG

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

DRUG

6(Lipitor®, Ezetrol®)

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

DRUG

6 (Ezetrol®)

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

DRUG

6 (Lipitor®)

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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical

  lead INDUSTRY

Principal Investigators

• Min Soo Park, Ph.D. M.D · Severance Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2015-02-28

Completion

2015-02-28

Countries

• South Korea

Study Locations