Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time to Maximum Plasma Concentration (Tmax)
研究概览
简要总结
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.
详细描述
Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within 30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years of age at the Screening Visit.
- •Subjects undergoing tonsillectomy with or without removal of the adenoids.
- •Able and willing to comply with all study visits and procedures.
- •Willing and capable of providing written informed consent.
排除标准
- •History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
- •Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study.
- •Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration.
- •Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.
研究组 & 干预措施
EXPAREL
Single administration of EXPAREL 133 mg (10 mL).
干预措施: EXPAREL (Drug)
结局指标
主要结局
Time to Maximum Plasma Concentration (Tmax)
时间窗: From time of study drug administration through Day 7 postdose
Apparent Terminal Elimination Half-life
时间窗: From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))
时间窗: From time of study drug administration through Day 7 postdose
The Apparent Terminal Elimination Rate Constant (λz)
时间窗: From time of study drug administration through Day 7 postdose
Maximum Plasma Concentration (Cmax)
时间窗: From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))
时间窗: From time of study drug administration through Day 7 postdose
次要结局
未报告次要终点