Qt Interval, Variation in
Conditions
Brief summary
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.
Interventions
DRUGCelecoxib
Celecoxib 400mg capsule
DRUGMoxifloxacin
Moxifloxacin 400mg tablet
OTHERWater
Pure water 150ml
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults between 19-year-old and 40-year-old during the screening day * BMI between 19 kg/m² and 30 kg/m² during the screening day * Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs * Wiling to participate whole clinical trial periods
Exclusion criteria
* Person who is able to clinically affect to the study through ECG result during the screening day * Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death. * Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study * Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc. * Was administered any drug of other clinical study within 90 days from the randomization day. * Donated whole blood within 60days or apheresis within 30 days from the randomization day. * Took any medicine or oriental medicine within 2 weeks, or general pharmaceuticals within 7 days from the randomization day. (For general pharmaceuticals circumstances, PI could decide whether he/she is suitable for the study) * No intention to take contraceptive which is approved as clinical way, or is planning on giving their sperm or egg during the whole clinical trial. * Average alcohol consumption per week: \>140g * Average smoking per day: \>20 * Average grapefruit juice consumption per day: \>4 glasses * systolic blood pressure \<100 mmHg or \>150 mmHg, or diastolic pressure \<70 mmHg or \>100mmHg * Over 2 times from the maximum reference interval of AST and ALT levels in the blood. * eGFR by MDRD from creatinine in the blood is less than 30 mL/min. * doesn't show negative reaction from HIV Test, B hepatitis test, or C hepatitis test * For woman, doesn't show negative reaction from pregnancy test * PI decides the person is not suitable to participate the clinical study with other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QTc interval, read manually | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RR duration, measured automatically | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
| QRS duration, measured automatically | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
| Change in QTc , measured automatically | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
| ventricular rate, measured automatically | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
| Area under the curve within a dosing interval at steady state | 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) | which is analyzed at the date of final administration of celecoxib |
| Maximum concentration at steady state | 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) | which is analyzed at the date of final administration of celecoxib |
| PR duration, measured automatically | -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 | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. |
| Minimum concentration at steady state | 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) | which is analyzed at the date of final administration of celecoxib |
| Area under the concentration-time curve time zero to the time of the last quantifiable concentration | 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) | which is analyzed at the date of final administration of moxifloxacin |
| Maximum concentration | 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) | which is analyzed at the date of final administration of moxifloxacin |
| Time to maximum concentration | 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) | which is analyzed at the date of final administration of moxifloxacin |
| Half-life | 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) | which is analyzed at the date of final administration of moxifloxacin |
| The apparent clearance | 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) | which is analyzed at the date of final administration of moxifloxacin |
| Time to maximum concentration at steady state | 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) | which is analyzed at the date of final administration of celecoxib |
Countries
South Korea
Outcome results
None listed