CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

NCT02288338 | Completed Phase 1 DMC

• 1 other identifier: 152DDI14016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

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

• Cmax,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

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

Secondary Outcomes (13)

• 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)

• %fluctuation of atorvastatin and free 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)

• t1/2 of atorvastatin and free ezetimibe

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

Study Arms (6)

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

1 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

1 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

2 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

2 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

3(Lipitor®, Ezetrol®) DRUG

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

3 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

3 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

4 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

4 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

5 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

5 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

6(Lipitor®, Ezetrol®) DRUG

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

Also known as: Lipitor® 40mg, Ezetrol® 10mg

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

6 (Ezetrol®) DRUG

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

Also known as: Ezetrol® 10mg

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

6 (Lipitor®) DRUG

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

Also known as: Lipitor® 40mg

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

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

ChongKunDang

Seoul, South Korea

Location

MeSH Terms

Interventions

Atorvastatin; Ezetimibe

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Study Officials

• Min Soo Park, Ph.D. M.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2014-11

Locations

KR (1)