A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG-651" in Healthy Volunteers
概览
- 阶段
- 1 期
- 干预措施
- Polmacoxib
- 疾病 / 适应症
- Healthy
- 发起方
- CrystalGenomics, Inc.
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Cmax of polmacoxib and pregabalin
- 状态
- 已完成
- 最后更新
- 3年前
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
研究者
入排标准
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 A
Pregabalin + Polmacoxib
干预措施: Polmacoxib
Group A
Pregabalin + Polmacoxib
干预措施: Pregabalin
Group B
Polmacoxib
干预措施: Polmacoxib
Group C
Pregabalin
干预措施: Pregabalin
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.