Status:
COMPLETED
Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
Lead Sponsor:
Samsung Medical Center
Conditions:
Qt Interval, Variation in
Eligibility:
All Genders
19-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03822520
Start Date
June 30 2017
End Date
May 25 2018
Last Update
January 30 2019
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea