The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered. Group 2 is administered in reverse order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Severance Hospital
Seoul, Seoul, South Korea
CKD-501 AUC
Time frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
CKD-501 Cmax
Time frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
CKD-501 Tmax
Time frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
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