An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean Percent Adhesion
研究概览
简要总结
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
- •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
- •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 local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application
研究组 & 干预措施
Lidocaine Patch (Sequence T1T2)
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2.
干预措施: lidocaine topical system 1.8% (Drug)
Lidocaine Patch (Sequence T1T2)
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2.
干预措施: lidocaine patch 5% (Drug)
Lidocaine Patch (Sequence T2T1)
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2.
干预措施: lidocaine topical system 1.8% (Drug)
Lidocaine Patch (Sequence T2T1)
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2.
干预措施: lidocaine patch 5% (Drug)
结局指标
主要结局
Mean Percent Adhesion
时间窗: 12 hours post-dose
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.
次要结局
未报告次要终点