This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Celecoxib 400mg capsule
Moxifloxacin 400mg tablet
Pure water 150ml
Samsung Medical Center
Seoul, South Korea
Change in QTc interval, read manually
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Change in QTc , measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
ventricular rate, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
PR duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
RR duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
QRS duration, measured automatically
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time frame: -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Area under the curve within a dosing interval at steady state
which is analyzed at the date of final administration of celecoxib
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Maximum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Time to maximum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Minimum concentration at steady state
which is analyzed at the date of final administration of celecoxib
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Area under the concentration-time curve time zero to the time of the last quantifiable concentration
which is analyzed at the date of final administration of moxifloxacin
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Maximum concentration
which is analyzed at the date of final administration of moxifloxacin
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Time to maximum concentration
which is analyzed at the date of final administration of moxifloxacin
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Half-life
which is analyzed at the date of final administration of moxifloxacin
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
The apparent clearance
which is analyzed at the date of final administration of moxifloxacin
Time frame: 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)