NCT02264080已完成1 期
Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Multiple Oral Dose Study
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
- 12
- 主要终点
- Distribution volume
研究概览
简要总结
Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a multiple dose to healthy adult male volunteers in double blind manner.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.
- •Age: 20-30 years old
- •Body weight: 50-80 kg
- •Obesity index: within +/-20% of the standard body weight [standard body weight = (height - 100) x 0.9]
- •Those who have received screening examinations listed in Table 1 within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
- •Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic
排除标准
- •Those who have a history of allergic reaction or hypersensitivity to drugs
- •Those who have received any kind of drug(s) within one week prior to the administration of the investigational product.
- •Those who have ingested alcoholic drink within two days before the administration of the investigational product
- •Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
- •Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
- •Those who participated in Phase I single dose study of the investigational product
- •Those who have a history of liver or renal disease
- •Those who are judged as ineligible for the clinical study by the investigator
研究组 & 干预措施
WAL2014
Experimental
干预措施: WAL2014 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Distribution volume
时间窗: up to day 14
Total clearance
时间窗: up to day 14
Number of subjects with adverse events
时间窗: up to 22 days
Maximum concentration of the analyte in plasma (Cmax)
时间窗: up to day 14
Time to reach maximum plasma concentration (tmax)
时间窗: up to day 14
Area under the plasma concentration-time curve (AUC)
时间窗: up to day 14
Urinary excretion rate
时间窗: up to day 14
Minimum plasma concentration (Cmin)
时间窗: up to day 14
Mean residence time (MRT)
时间窗: up to day 14
Terminal half-life (t1/2)
时间窗: up to day 14
次要结局
未报告次要终点
研究者
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