A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Arm A, Cmax,ss of Celecoxib
研究概览
简要总结
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
详细描述
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
- •Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- •Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- •Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- •Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
研究组 & 干预措施
Cohort 1, A (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
干预措施: Celecoxib (Drug)
Cohort 1, B (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 1, B (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
干预措施: Celecoxib (Drug)
Cohort 1, A (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 2, C (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 2, C (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
干预措施: Naproxen (Drug)
Cohort 2, D (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 2, D (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
干预措施: Naproxen (Drug)
Cohort 3, E (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 3, E (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
干预措施: Meloxicam (Drug)
Cohort 3, F (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
干预措施: DWP14012 (Drug)
Cohort 3, F (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
干预措施: Meloxicam (Drug)
结局指标
主要结局
Arm A, Cmax,ss of Celecoxib
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm A, AUCτ,ss of Celecoxib
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm B, Cmax,ss of DWP14012
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm B, AUCτ,ss of DWP14012
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm C, Cmax,ss of Naproxen
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm C, AUCτ,ss of Naproxen
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm D, Cmax,ss of DWP14012
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm D, AUCτ,ss of DWP14012
时间窗: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm E, Cmax,ss of Meloxicam
时间窗: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Maximum measured plasma concentration at steady-state
Arm E, AUCτ,ss of Meloxicam
时间窗: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Area under the plasma concentration-time curve
次要结局
未报告次要终点