NCT02288338

CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-11-11
• Last updated: 2015-03-10

Locations

1 site across 1 country: South Korea