Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
研究概览
简要总结
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
laboratory-blinded, 3-period, 3-sequence, crossover study
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
- •Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:
- •non- or ex-smokers
- •body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
- •negative pregnancy test for female subjects
- •healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
排除标准
- 未提供
研究组 & 干预措施
Abdominal application of 2% CHG
干预措施: Chlorhexidine Gluconate (Drug)
Groin application of 2% CHG
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
时间窗: Up to 24 hours after product application
A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.
次要结局
- Number of Subjects With of Treatment Emergent Adverse Events.(Up to 24 hours after product application, overall, up to 3 weeks)