An Open-Label Pharmacokinetic Study of the Synera Patch Applied for 2-, 4-, and 12-hours and a Lidocaine/Tetracaine Patch Without Heat Applied for 4 Hours in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of Synera after application of 4 patches
研究概览
简要总结
This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.
详细描述
The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •be at least 18 years of age
- •be a nonsmoker
- •have a body mass index (BMI) ≥ 18.5 and < 30.0
排除标准
- •known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics.
- •have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied.
- •have a history or current evidence of any hepatic impairment.
- •have failed the urine drug screen.
- •have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days.
- •have donated blood or plasma within the past 30 days.
- •have participated in a clinical research study within the past 30 days.
- •are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control
研究组 & 干预措施
Synera
Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat ("no heat patches") and were crossed over during Study Session 3.
干预措施: Synera (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of Synera after application of 4 patches
时间窗: 0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose
Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours
次要结局
- Area under the plasma concentration versus time (AUC) of Synera(0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose)
- Number of participants with adverse events(24 days)