An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
研究概览
简要总结
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
详细描述
To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.
Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subject older than 19 years men at the screening
- •Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
- •Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
- •Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
- •* BMI = Weight(kg)/ Height(m)2
- •Individuals who had agreed to participate in the study
- •Individuals without mental illness history within five year prior to the screening
- •Individuals without a medical history of gastrointestinal operations that may affect drug absorption
- •Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration
排除标准
- •Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
- •Individuals who had excessive drinking within the 1 month
- •*Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
- •Individuals who had taken any medication within 10 days prior to the first day of dosing
- •Individuals who were deemed to be inappropriate to participate in the study by the investigator
- •Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
- •Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
- •Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
- •Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Individuals with orthostatic hypotension
- •Individuals with severe hepatopathy
- •Individuals who had taken alpha-1 blocker
- •Individuals who had history of micturition syncope
- •Individuals with nephropathy
- •Elderly person
- •Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
- •Individuals who had taken CYP3A4 inhibitor
- •Individuals who had taken antihypertensive drug(s)
研究组 & 干预措施
Reference/Test
- Period 1: Harnal-D Tab. 1T
- Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T
干预措施: Harnal-D Tab. (Drug)
Reference/Test
- Period 1: Harnal-D Tab. 1T
- Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T
干预措施: Chong Kun Dang Tamsulosin HCl Tab. (Drug)
Test/Reference
- Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T
- Period 2: Harnal-D Tab. 1T
干预措施: Harnal-D Tab. (Drug)
Test/Reference
- Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T
- Period 2: Harnal-D Tab. 1T
干预措施: Chong Kun Dang Tamsulosin HCl Tab. (Drug)
结局指标
主要结局
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
时间窗: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
时间窗: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t
次要结局
未报告次要终点