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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in QTc interval, read manually
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Celecoxib, Moxifloxacin, Water in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
干预措施: Celecoxib (Drug)
Celecoxib, Moxifloxacin, Water in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
干预措施: Moxifloxacin (Drug)
Celecoxib, Moxifloxacin, Water in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
干预措施: Water (Other)
Celecoxib, Water, Moxifloxacin in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
干预措施: Celecoxib (Drug)
Celecoxib, Water, Moxifloxacin in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
干预措施: Moxifloxacin (Drug)
Celecoxib, Water, Moxifloxacin in order
- Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
干预措施: Water (Other)
Moxifloxacin, Water, Celecoxib in order
- Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Celecoxib (Drug)
Moxifloxacin, Water, Celecoxib in order
- Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Moxifloxacin (Drug)
Moxifloxacin, Water, Celecoxib in order
- Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Water (Other)
Water, Moxifloxacin, Celecoxib in order
- Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Celecoxib (Drug)
Water, Moxifloxacin, Celecoxib in order
- Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Moxifloxacin (Drug)
Water, Moxifloxacin, Celecoxib in order
- Intervention Pure water: Water 150ml by mouth without any drug, once for one day
Wash-out period (3~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day
Wash-out period (3~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
干预措施: Water (Other)
结局指标
主要结局
Change in QTc interval, read manually
时间窗: -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
which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
次要结局
- Change in QTc , measured automatically(-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)
- Half-life(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(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))
- PR duration, measured automatically(-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(-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)
- Time to maximum concentration at steady state(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))
- ventricular rate, measured automatically(-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(-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)
- Maximum concentration at steady state(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(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(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(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))
- Area under the curve within a dosing interval at steady state(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(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))
研究者
Jung-Ryul Kim
Professor
Samsung Medical Center