Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib (NCT03822520) | Clinical Trial Compass
CompletedPhase 1
Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
South Korea28 participantsStarted 2017-06-30
Plain-language 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.
Who can participate
Age range19 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Change in QTc interval, read manually
Timeframe: -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