NCT01527734已完成1 期
COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS-DETERMINATIONS IN BLOOD AND URINE
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX
研究概览
简要总结
The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Normal renal function
排除标准
- •History of multiple clinically significant drug allergies
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Tetrodotoxin, TTX
Experimental
干预措施: Tetrodotoxin (Drug)
结局指标
主要结局
Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX
时间窗: 26 timepoints over 48 hours
PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 \& 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values.
次要结局
- Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX(signage of the ICF to Day 10)
研究者
研究点 (1)
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