NCT02261090已完成1 期
A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male 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
- 14
- 主要终点
- Urine total exposure (Aeτ,ss)
研究概览
简要总结
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy males
- •Participants should be ranging from 21 to 50 years of age
- •Body mass index (BMI) within 18.5 to 29.9 kg/m2
- •In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on in-house trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- •Any laboratory value outside the clinically accepted reference range
- •Excessive physical activities within the last week before the trial or during the trial
- •Hypersensitivity to pramipexole, or other dopamine agonists
- •Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
- •A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/mL)
- •Subjects involved in passenger transport or operation of dangerous machines
研究组 & 干预措施
immediate release (IR) formulation
Active Comparator
干预措施: Pramipexole immediate release (IR) tablets (Drug)
结局指标
主要结局
Urine total exposure (Aeτ,ss)
时间窗: up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)
时间窗: up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)
时间窗: up to 168 hours after each drug administration
Plasma total exposure (AUCτ,ss)
时间窗: up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)
时间窗: up to 168 hours after each drug administration
Plasma average concentration (Cavg)
时间窗: up to 168 hours after each drug administration
次要结局
- AUC0-6,11 for the immediate release (IR) formulation(day 7 of visit 2)
- Cmax for the IR formulation(up to 168 hours after drug administration in visit 2)
- Cmin for the IR formulation(up to 168 hours after drug administration in visit 2)
- tmax for the IR formulation(up to 168 hours after drug administration in visit 2)
- Urinary excretion (Ae) for the IR formulation(up to 168 hours after drug administration in visit 2)
- tmax,4 for the SR formulation(up to 96 hours after drug administration in visit 3-5, 7 and 9)
- t1/2,4 for the SR formulation(up to 96 hours after drug administration in visit 9)
- Number of subjects with adverse events(up to 8 days after last drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
- Assessment of global tolerability by investigator on a 5-point scale(at the end of each of the visits 2 to 9)
- Urinary excretion (Ae) for the SR formulation(up to 168 hours after drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 8 days after last drug administration)
研究者
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