Pharmacokinetics, Safety and Tolerability of Single Oral Doses (0.1, 0.2, 0.4 and 0.8 mg) of Tamsulosin Hydrochloride in Children With Voiding Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percentage of the AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)
研究概览
简要总结
To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in children with voiding disorders
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls with (or a history of) voiding disorders
- •Age: 5 to 15 years
- •Body weight and height ≥ 5 % and ≤95 % of normal using nomograms
- •Signed and dated written informed consent by the parent or guardian and, where appropriate, informed assent by the child, prior to admission into the study in accordance with good clinical practice (GCP) and the local legislation, has been obtained
排除标准
- •Clinically significant abnormalities found at, or before randomization at Visit 2 [i.e., abnormal: vital signs (e.g., hypotension), ECGs, as well as significant findings during the physical examination], as determined by the investigator
- •Clinically relevant conditions including, but not limited to, the following: gastrointestinal, cardiovascular (e.g., subjects that fall above the 90th percentile according to the blood pressure nomogram in the ISF), hepatic, renal, hematologic, metabolic (including diabetes mellitus), immunological, hormonal disorders, respiratory disease or cancer
- •Subjects who had surgery within the last 30 days
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Subjects that have a neurological impairment or psychiatric disorder that prevents their comprehension of consent and their ability to comply with the protocol
- •History of relevant orthostatic hypotension, fainting spells or blackouts. Postdural symptoms occurring (e.g., lightheadedness, dizziness, and fainting) with or without a change in blood pressure and / or pulse rate within 6 weeks of Visit 2
- •Relevant acute infections, especially with regards to urinary tract infections or active genitourinary infection
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Subjects with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers
- •Use of medications classified as cytochrome P450 3A4 (CYP3A4) inhibitors and inducers within 10 days prior to administration of trial drug
- •Intake of drugs with a long half-life (> 24 hours) within less than 10 half-lives of the respective drug prior to administration
- •Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
- •Inability to comply with dietary regimen of study center
- •Pregnancy or subjects that are breast feeding
- •All subjects parents and guardians in the investigator's opinion who cannot understand the terms of the informed consent form and subject information
研究组 & 干预措施
Tamsulosin hydrochloride, medium dose
干预措施: Tamsulosin hydrochloride, medium dose (Drug)
Tamsulosin hydrochloride, very low dose
干预措施: Tamsulosin hydrochloride, very low dose (Drug)
Tamsulosin hydrochloride, low dose
干预措施: Tamsulosin hydrochloride, low dose (Drug)
Tamsulosin hydrochloride, high dose
干预措施: Tamsulosin hydrochloride, high dose (Drug)
结局指标
主要结局
Percentage of the AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)
时间窗: Up to 26 hours after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single-dose administration (AUC0-∞)
Terminal rate constant of the analyte in plasma (λz)
时间窗: Up to 26 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
时间窗: Up to 26 hours after drug administration
Maximum concentration of the analyte in plasma (Cmax)
时间窗: Up to 26 hours after drug administration
Time from dosing to maximum concentration of the analyte in plasma (tmax)
时间窗: Up to 26 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
时间窗: Up to 26 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
时间窗: Up to 26 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
时间窗: Up to 26 hours after drug administration
Weight-normalized AUC0-∞
时间窗: Up to 26 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
时间窗: Up to 26 hours after drug administration
Weight-normalized Cmax
时间窗: Up to 26 hours after drug administration
Weight-normalized (AUC0-tz)
时间窗: Up to 26 hours after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single-dose administration (AUC0-tz)
次要结局
- Number of patients with clinically relevant changes in physical examination(Pre-dose, up to 26 hours after drug administration)
- Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate)(Pre-dose, up to 26 hours after drug administration)
- Number of patients with clinically relevant changes from baseline in orthostatic test(Pre-dose and 4 hours after drug administration)
- Number of patients with clinically relevant changes in 12-lead ECG(Pre-dose, up to 26 hours after drug administration)
- Number of patients with clinically relevant changes from baseline in laboratory tests(Pre-dose and 26 hours after drug administration)
- Global assessment of tolerability by the investigator on a 5-point rating scale(26 hours after drug administration)
- Number of patients with adverse events(Up to 7 days after drug administration)