An Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Cross-over, Pharmacokinetic and Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Fasting, Healthy, Adult, Human Subjects, With Physical Exercise, Heat and Normal Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Peak plasma concentration (Cmax) of lidocaine
研究概览
简要总结
The objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.
详细描述
In this open-label, three-period crossover study, 12 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have three lidocaine topical systems applied to their back for 12 hours with 7-day washout between treatments. In each treatment period, the subject will either exercise (Treatment A), apply a heating pad (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 48 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy based on by medical history, laboratory work, and physical exam
- •Be at least 18 years of age
- •If childbearing potential, use of acceptable form of birth control
- •In the case of females of childbearing potential, have a negative serum pregnancy test
排除标准
- •Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
- •Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
- •Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
- •History of addiction, abuse, and misuse of any drug
- •Use of nicotine-containing products within 30 days
研究组 & 干预措施
Lidocaine Topical System with Moderate Exercise (Treatment A)
Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. Subjects are instructed to exercise 30 minutes on an exercise bicycle, achieving at heart rate of approximately 108 bpm. Exercise is performed after 2.5 hours, 5.5 hours, and 8.5 hours after topical system application.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine Topical System with Heat Applied (Treatment B)
Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. A heating pad is applied for 20 minutes at 2.5, 5.5, and 8.5 hours after the product is applied.
干预措施: Lidocaine topical system 1.8% (Drug)
Lidocaine Topical System under normal conditions (Treatment C)
Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. No heat application or exercise is performed during this period.
干预措施: Lidocaine topical system 1.8% (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 and 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 48 hours
时间窗: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
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 and 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
Cumulative Adhesion Score
时间窗: 0, 0.5, 3, 6, 9, 12 hours post-dose
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point.
次要结局
- Dermal Response Score(12.5 and 14 hours post-dose)