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

• Status: Completed
• Trial end date: 2018-05-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Celecoxib; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.