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

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

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.

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.