The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)
研究概览
简要总结
The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.
详细描述
This trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside A in subjects who received the treatment of WH-1 ointment for diabetic foot ulcers. A total of 12 subjects will be completed in study. Each subject will be applied the one dose of WH-1 ointment on Day 1 following with the blood sampling collection, then twice a day of WH-1 application from Day 2 to Day 13, and another blood sampling collection scheduled on Day 14 after one dose application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female is at least 20 years of age;
- •Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;
- •The target diabetic foot ulcer must have the following characteristics:
- •≤ Grade 2 per Wagner Ulcer Classification System;
- •Lower limbs;
- •No-infected;
- •A cross-sectional area of between 1 and 25 cm2 post-debridement;
- •If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;
- •Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.
排除标准
- •Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;
- •Poor nutritional status defined as an albumin < 2.5 g/dL;
- •AST and/or ALT > 3X of the normal upper limit;
- •Clearance of Creatinine (Ccr) < 30 ml/min;
- •Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;
- •A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject' s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
- •Subjects who have received an experimental agent within 30 days, prior to enroll.
- •Subjects who have received WH-1 ointment within 30 days, prior to enroll.
- •Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.
- •Judged by the investigator not to be suitable for the study for any other reason.
研究组 & 干预措施
WH-1 ointment
WH-1 ointment(1.25%),15g ointment per tube.
干预措施: WH-1 ointment (Drug)
结局指标
主要结局
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)
时间窗: Day1; Day14
AUC0-∞, AUC0-t, Cmax: 1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞) 2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t) 3. Maximum observed level (Cmax) Cmax,ss, AUC0-τ: 1. Maximum observed plasma concentration at steady state (Cmax,ss) 2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ).
次要结局
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)(Day1)
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)(Day14)