Clinical trial NCT02288338: CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
Official title: CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: AUCτ,ss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: Cmax,ss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Secondary outcomes:
measure: AUCinf,ss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: Cavg,ss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: %fluctuation of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: tmax,ss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: t1/2 of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: CL/Fss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: Vd/Fss of atorvastatin and free ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: AUCτ,ss of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: AUCinf,ss of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: Cmax,ss of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: tmax,ss of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: t1/2 of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
measure: metabolic ratio of 2-hydroxy atorvastatin and total ezetimibe
timeFrame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChongKunDang
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D. M.D
role: PRINCIPAL_INVESTIGATOR
References: