CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): 1 (Lipitor®); 1 (Ezetrol®); 1 (Lipitor®, Ezetrol®); 2 (Ezetrol®); 2(Lipitor®, Ezetrol®); 2 (Lipitor®); 3(Lipitor®, Ezetrol®); 3 (Lipitor®); 3 (Ezetrol®); 4 (Lipitor®); 4(Lipitor®, Ezetrol®); 4 (Ezetrol®); 5 (Ezetrol®); 5 (Lipitor®); 5 (Lipitor®, Ezetrol®); 6(Lipitor®, Ezetrol®); 6 (Ezetrol®); 6 (Lipitor®)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days; atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days; After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other intervention name(s): Lipitor® 40mg; Ezetrol® 10mg; Lipitor® 40mg, Ezetrol® 10mg; Ezetrol® 10mg; Lipitor® 40mg, Ezetrol® 10mg; Lipitor® 40mg; Lipitor® 40mg, Ezetrol® 10mg; Lipitor® 40mg; Ezetrol® 10mg; Lipitor® 40mg; Lipitor® 40mg, Ezetrol® 10mg; Ezetrol® 10mg; Ezetrol® 10mg; Lipitor® 40mg; Lipitor® 40mg, Ezetrol® 10mg; Lipitor® 40mg, Ezetrol® 10mg; Ezetrol® 10mg; Lipitor® 40mg
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment