An Open-label, Randomized, Four-treatment, Four-sequence, Four-period, Crossover, Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of lidocaine
研究概览
简要总结
This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.
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 60 Years（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
- •Body mass index ranging between 18.0-32.5 kg/m2, inclusive
- •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)
- •Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
- •History of addiction, abuse, or misuse of any drug
- •Use of nicotine-containing products within 30 days
研究组 & 干预措施
SP-103 (1 topical system)
One topical system applied to the skin on the back for 12 hours.
干预措施: SP-103 (Drug)
SP-103 (2 topical systems)
Two topical systems applied to the skin on the back for 12 hours.
干预措施: SP-103 (Drug)
SP-103 (3 topical systems)
Three topical systems applied to the skin on the back for 12 hours.
干预措施: SP-103 (Drug)
ZTlido
Three topical systems applied to the skin on the back for 12 hours.
干预措施: ZTlido (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 12 hour topical system application
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 plasma
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
- Mean adhesion score(0, 3, 6, 9, 12 hours post-dose)
- Dermal response score(12.5 and 14 hours post-dose)