A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG-651" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Cmax of polmacoxib and pregabalin
研究概览
简要总结
This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.
详细描述
Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each)
[Group A] Pregabalin+ Polmacoxib. [Group B] Polmacoxib [Group C] Pregabalin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (open label)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate Biochemistry, Urinalysis, Serology and so on.
- •Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation.
- •Negative pregnancy test (hCG) and agree to contraception during the trial.
排除标准
- •History of hypersensitivity to investigational products.
- •History of hypersensitivity or allergic reaction to sulfonamide.
- •Patients with a history of asthma, acute rhinitis, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors)
- •Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.
研究组 & 干预措施
Group C
Pregabalin
干预措施: Pregabalin (Drug)
Group A
Pregabalin + Polmacoxib
干预措施: Pregabalin (Drug)
Group B
Polmacoxib
干预措施: Polmacoxib (Drug)
Group A
Pregabalin + Polmacoxib
干预措施: Polmacoxib (Drug)
结局指标
主要结局
Cmax of polmacoxib and pregabalin
时间窗: upto 4 weeks
Maximum Observed Plasma Concentration
AUC of polmacoxib and pregabalin
时间窗: upto 4 weeks
Area Under the Concentration-Time Curve
The Number of Participants Who Experienced Adverse events (AEs)
时间窗: upto 4 weeks
A non-serious adverse event is any untoward medical occurrence. A serious adverse event is any adverse event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage.
次要结局
未报告次要终点