CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 4 (Lipitor®); Drug: 5 (Lipitor®, Ezetrol®); Drug: 5 (Ezetrol®); Drug: 6 (Ezetrol®); Drug: 1 (Lipitor®, Ezetrol®); Drug: 3(Lipitor®, Ezetrol®); Drug: 6 (Lipitor®); Drug: 4 (Ezetrol®); Drug: 2 (Lipitor®); Drug: 3 (Lipitor®); Drug: 4(Lipitor®, Ezetrol®); Drug: 2(Lipitor®, Ezetrol®); Drug: 1 (Ezetrol®); Drug: 2 (Ezetrol®); Drug: 6(Lipitor®, Ezetrol®); Drug: 3 (Ezetrol®); Drug: 1 (Lipitor®); Drug: 5 (Lipitor®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02288338

152DDI14016

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: 1 (Lipitor®)

Drug: 1 (Ezetrol®)

Drug: 1 (Lipitor®, Ezetrol®)

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

Experimental group

Description:

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

Treatment:

Drug: 2 (Ezetrol®)

Drug: 2(Lipitor®, Ezetrol®)

Drug: 2 (Lipitor®)

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

Experimental group

Description:

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

Treatment:

Drug: 3 (Ezetrol®)

Drug: 3 (Lipitor®)

Drug: 3(Lipitor®, Ezetrol®)

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

Experimental group

Description:

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

Treatment:

Drug: 4(Lipitor®, Ezetrol®)

Drug: 4 (Ezetrol®)

Drug: 4 (Lipitor®)

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

Experimental group

Description:

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

Treatment:

Drug: 5 (Lipitor®)

Drug: 5 (Ezetrol®)

Drug: 5 (Lipitor®, Ezetrol®)

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

Experimental group

Description:

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

Treatment:

Drug: 6(Lipitor®, Ezetrol®)

Drug: 6 (Lipitor®)

Drug: 6 (Ezetrol®)