NCT00861549已完成1 期
Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers
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
- 32
- 试验地点
- 1
- 主要终点
- PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite
研究概览
简要总结
The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must have signed and dated informed consent form.
- •Subjects must be ≧ 18 and ≦ 40 years old, healthy, non-smoking male.
- •Subjects with body weight within ± 20% ideal body weight
- •Subjects with urinalysis data within acceptable range, including pH, blood, glucose and protein
- •Subjects with laboratory evaluations data within acceptable range, including serum chemistry examinations (glucose, total cholesterol, TG, SGOT, SGPT, GSP, alkaline phosphatase, total bilirubin, total protein, albumin, r-GT, BUN, creatinine, uric acid) and hematology (complete blood count and platelets)
- •Subjects with acceptable ECG and chest x-ray
排除标准
- •Subjects had taken any drugs within 14 days prior to screening.
- •Subjects with history of glaucoma
- •Subjects with history of ileus
- •Subjects with history of benign prostate hypertrophy with urine retention
- •Subjects with history of myasthenia gravis
- •Subjects with history of asthma
- •Subject with history of any other medical conditions that, in the opinion of the investigator, compromised subject safety or ability to comply with study procedures
- •Subjects with history of drug or alcohol addiction or abuse within 1 year prior to screening
- •Subjects with hypersensitivity to phencynonate hydrochloride or other drugs with similar chemical structure
- •Subjects had donated blood more than 250 mL within the pervious 3 months prior to study
- •Subjects had received any investigational drugs within 1 month prior to screening
研究组 & 干预措施
cohort 1
Experimental
1mg / 0.5 tablet
干预措施: Phencynonate hydrochloride (Drug)
cohort 2
Experimental
2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China
干预措施: Phencynonate hydrochloride (Drug)
cohort 3
Experimental
4mg / 2 tablets
干预措施: Phencynonate hydrochloride (Drug)
结局指标
主要结局
PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite
时间窗: 5 or 10 days
Safety Variables:AE/lab. exam./PE/Vital signs/ECG
时间窗: 5 to 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
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