Phase 1, open-label, non-randomized, three-treatment, one-sequence interaction study to evaluate the PK interactions between CKD-508, midazolam, and rosuvastatin in healthy adult male participants
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Research Site
Glendale, California, United States
Cmax of midazolam
Maximum plasma concentrations of midazolam after single dose
Time frame: 24 hours
AUClast of midazolam
Area under the concentration-time curve of midazolam after single dose
Time frame: 24 hours
AUCinf of midazolam
Area under the concentration-time curve extrapolated to infinity of midazolam
Time frame: From 0 hours to 24 hours on Day 1 and Day 24
Cmax of Rosuvastatin
Maximum plasma concentrations of rosuvastatin after single dose
Time frame: 72 hours
AUClast of rosuvastatin
Area under the concentration-time curve of rosuvastatin after single dose
Time frame: 72 hours
AUCinf of rosuvastatin
Area under the concentration-time curve extrapolated to infinity of rosuvastatin
Time frame: From 0 hours to 72 hours on Day 1 and Day 24
Cmax,ss of CKD-508
Maximum plasma concentration at steady state of CKD-508
Time frame: 24 hours
AUCtau,ss of CKD-508
Area under the concentration time curve until the end of dosing interval at steady state of CKD-508
Time frame: 24 hours
Cmin,ss of CKD-508
Minimum plasma concentration at steady state of CKD-508
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Time frame: 24 hours