HealthyPhase 1NCT02288338
CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
A Phase 1 study testing 1 (Lipitor®), 1 (Ezetrol®) and 1 (Lipitor®, Ezetrol®) in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1 (Lipitor®), 1 (Ezetrol®) and 1 (Lipitor®, Ezetrol®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration
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
Read the detailed description
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
- Conditions
- Healthy
- Being tested
- 1 (Lipitor®), 1 (Ezetrol®), 1 (Lipitor®, Ezetrol®), 2 (Ezetrol®), 2(Lipitor®, Ezetrol®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 (Lipitor®)Drug
Also called Lipitor® 40mg
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
1 (Ezetrol®)Drug
Also called Ezetrol® 10mg
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
1 (Lipitor®, Ezetrol®)Drug
Also called Lipitor® 40mg, Ezetrol® 10mg
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2 (Ezetrol®)Drug
Also called Ezetrol® 10mg
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
2(Lipitor®, Ezetrol®)Drug
Also called Lipitor® 40mg, Ezetrol® 10mg
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
Also called Lipitor® 40mg
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3(Lipitor®, Ezetrol®)Drug
Also called Lipitor® 40mg, Ezetrol® 10mg
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
3 (Lipitor®)Drug
Also called Lipitor® 40mg
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
3 (Ezetrol®)Drug
Also called Ezetrol® 10mg
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
4 (Lipitor®)Drug
Also called Lipitor® 40mg
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
4(Lipitor®, Ezetrol®)Drug
Also called Lipitor® 40mg, Ezetrol® 10mg
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
Also called Ezetrol® 10mg
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5 (Ezetrol®)Drug
Also called Ezetrol® 10mg
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
5 (Lipitor®)Drug
Also called Lipitor® 40mg
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
5 (Lipitor®, Ezetrol®)Drug
Also called Lipitor® 40mg, Ezetrol® 10mg
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
Also called Lipitor® 40mg, Ezetrol® 10mg
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Ezetrol®)Drug
Also called Ezetrol® 10mg
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
6 (Lipitor®)Drug
Also called Lipitor® 40mg
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: 6(Lipitor®, Ezetrol®); Drug: 6 (Ezetrol®); Drug: 6 (Lipitor®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Secondary outcomes (13)
AUCinf,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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Cavg,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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
%fluctuation 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
tmax,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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
t1/2 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
CL/Fss 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Vd/Fss 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
AUCτ,ss of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
AUCinf,ss of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Cmax,ss of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
tmax,ss of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
t1/2 of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
metabolic ratio of 2-hydroxy atorvastatin and total 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
Measured: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D. M.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288338
- Sponsor's protocol ID
- 152DDI14016
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration
- ClinicalTrials.gov ID
- NCT02288338
- Acronym / sponsor ID
- 152DDI14016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®) | Experimental | Drug: 1 (Lipitor®), Drug: 1 (Ezetrol®), Drug: 1 (Lipitor®, Ezetrol®)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 |
| 2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®) | Experimental | Drug: 2 (Ezetrol®), Drug: 2(Lipitor®, Ezetrol®), Drug: 2 (Lipitor®)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 |
| 3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®) | Experimental | Drug: 3(Lipitor®, Ezetrol®), Drug: 3 (Lipitor®), Drug: 3 (Ezetrol®)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 |
| 4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®) | Experimental | Drug: 4 (Lipitor®), Drug: 4(Lipitor®, Ezetrol®), Drug: 4 (Ezetrol®)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 |
| 5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®) | Experimental | Drug: 5 (Ezetrol®), Drug: 5 (Lipitor®), Drug: 5 (Lipitor®, Ezetrol®)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 |
| 6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®) | Experimental | Drug: 6(Lipitor®, Ezetrol®), Drug: 6 (Ezetrol®), Drug: 6 (Lipitor®)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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 (Lipitor®)Also: Lipitor® 40mgatorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®) |
| 1 (Ezetrol®)Also: Ezetrol® 10mgAfter 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®) |
| 1 (Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgAfter 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®) |
| 2 (Ezetrol®)Also: Ezetrol® 10mgezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®) |
| 2(Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgAfter 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®) |
| 2 (Lipitor®)Also: Lipitor® 40mgAfter 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®) |
| 3(Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgatorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®) |
| 3 (Lipitor®)Also: Lipitor® 40mgAfter 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®) |
| 3 (Ezetrol®)Also: Ezetrol® 10mgAfter 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®) |
| 4 (Lipitor®)Also: Lipitor® 40mgatorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®) |
| 4(Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgAfter 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®) |
| 4 (Ezetrol®)Also: Ezetrol® 10mgAfter 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®) |
| 5 (Ezetrol®)Also: Ezetrol® 10mgezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®) |
| 5 (Lipitor®)Also: Lipitor® 40mgAfter 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®) |
| 5 (Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgAfter 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®) |
| 6(Lipitor®, Ezetrol®)Also: Lipitor® 40mg, Ezetrol® 10mgatorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®) |
| 6 (Ezetrol®)Also: Ezetrol® 10mgAfter 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days | Drug | 6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®) |
| 6 (Lipitor®)Also: Lipitor® 40mgAfter 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days | Drug | 6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®) |
Primary outcome
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
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
13 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Soo Park, Ph.D. M.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 (Lipitor®), 1 (Ezetrol®) and 1 (Lipitor®, Ezetrol®) in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ,ss of atorvastatin and free ezetimibe (time frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.