Parallel Study to Evaluate the Pharmacokinetics, Dose Proportionality, Safety and Tolerability of GTX-101 (Bupivacaine Hydrochloride Metered Dose Spray) and Subcutaneous Injectable Bupivacaine in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC last
研究概览
简要总结
This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects.
The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.
Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form (ICF)
- •Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
- •Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
- •Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator
排除标准
- •History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- •History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
研究组 & 干预措施
50 mg GTX-101
干预措施: GTX-101 (Drug)
100 mg GTX-101
干预措施: GTX-101 (Drug)
200 mg GTX-101
干预措施: GTX-101 (Drug)
Bupivacaine subcutaneous injection
干预措施: Bupivacaine HCl subcutaneous injection (Drug)
结局指标
主要结局
AUC last
时间窗: From 0 hour to 240 hour after study drug administration
Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
Cmax between 0 hour to 240 hour after study drug administration
时间窗: From 0 hour to 240 hour after study drug administration
Maximum concentration occuring at Tmax
Tmax between 0 hour to 240 hour after study drug administration
时间窗: From 0 hour to 240 hour after study drug administration
Time of maximum observed concentration
AUC inf
时间窗: From 0 hour to 240 hour after study drug administration
Area under the concentration time curve extrapolated to infinity
次要结局
未报告次要终点