Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Peak plasma concentration (Cmax) of lidocaine
研究概览
简要总结
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy based on medical history, laboratory work, and physical exam
- •Be ≥18 and ≤65 years of age
- •Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
- •Must be free of any systemic or dermatologic disorder
排除标准
- •Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
- •Current use of opioids
- •Known hypersensitivity or allergy to any of the components of the product formulations
- •Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
研究组 & 干预措施
Lidocaine Patch (Sequence AB)
Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine Patch (Sequence AB)
Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours.
干预措施: Lidocaine patch 5% (Drug)
Lidocaine Patch (Sequence BA)
Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine Patch (Sequence BA)
Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours.
干预措施: Lidocaine patch 5% (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of lidocaine
时间窗: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity
时间窗: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa
Apparent dose
时间窗: 0 to 12 hours
Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours
时间窗: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
次要结局
未报告次要终点