Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Open-label, Negative and Positive Control, Crossover Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib in Healthy Adult Volunteers

Conditions
-----------------
Qt Interval, Variation in

Intervention / Treatment
-----------------
* Drug: Celecoxib
* Drug: Moxifloxacin
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib, Moxifloxacin, Water in order<br>Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3 6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3 6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day | Drug: Celecoxib<br>* Celecoxib 400mg capsule<br>* Other names: Celebrex;Drug: Moxifloxacin<br>* Moxifloxacin 400mg tablet<br>* Other names: Avelox;Other: Water<br>* Pure water 150ml<br>|
| Experimental: Celecoxib, Water, Moxifloxacin in order<br>Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3 6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3 6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day | Drug: Celecoxib<br>* Celecoxib 400mg capsule<br>* Other names: Celebrex;Drug: Moxifloxacin<br>* Moxifloxacin 400mg tablet<br>* Other names: Avelox;Other: Water<br>* Pure water 150ml<br>|
| Experimental: Moxifloxacin, Water, Celecoxib in order<br>Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3 6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3 6 days) Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days | Drug: Celecoxib<br>* Celecoxib 400mg capsule<br>* Other names: Celebrex;Drug: Moxifloxacin<br>* Moxifloxacin 400mg tablet<br>* Other names: Avelox;Other: Water<br>* Pure water 150ml<br>|
| Experimental: Water, Moxifloxacin, Celecoxib in order<br>Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3 6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3 6 days) Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days | Drug: Celecoxib<br>* Celecoxib 400mg capsule<br>* Other names: Celebrex;Drug: Moxifloxacin<br>* Moxifloxacin 400mg tablet<br>* Other names: Avelox;Other: Water<br>* Pure water 150ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QTc interval, read manually | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QTc , measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -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. | -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. | -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. | -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 | 
| QRS duration, measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |