A Study to Assess the Pharmacokinetics, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects
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 profile of the co-administration of IV granisetron and the Sancuso® patch
研究概览
简要总结
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.
详细描述
Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration.
Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female Caucasian subjects
- •Aged between 18 and 70 years, inclusive, at screening
- •BMI between 20.0 and 29.9 kg/m², inclusive.
- •Must demonstrate understanding of the purposes and risks of the study
- •Must agree to follow the restrictions and schedule of study procedures
排除标准
- •Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
- •Physical examination or screening investigation result that indicates subject is unfit for the study.
- •Scarring on upper arms.
- •Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
- •Recent use of prescribed or over the counter medication.
- •Participation in any clinical study or loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 60 days.
- •Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before the first study drug administration.
- •Lactating female subjects and female subjects of childbearing potential who are not willing to use an acceptable form of contraception during and for 90 days after the study.
研究组 & 干预措施
Sancuso® patch/IV granisetron
Subjects will receive 1 Sancuso® patch worn for 7 days (168 hours). Immediately after the patch has been applied on Day 1, IV granisetron will be administered over 30 seconds. Following patch removal at 168 hours, a new patch will be immediately applied to the opposite arm and will remain in place for a further 7 days (168 to 336 hours).
干预措施: granisetron (Drug)
结局指标
主要结局
Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch
时间窗: 0 to 336 hours post-dose
次要结局
- Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch(Up to 28 days post-dose)
- Patch adhesion and residual granisetron after patch(0 to 336 hours post-dose)
- Pharmacokinetic profile of repeated Sancuso® patch application(0 to 336 hours post-dose)