NCT02260024已完成1 期
A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole 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
- 15
- 主要终点
- AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
研究概览
简要总结
The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by results of the screening
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age ≥ 18 and ≤ 50 years
- •BMI ≥ 18.5 and ≤ 29.9 kg/m2
排除标准
- •Hypersensitivity to pramipexole or to other dopamine agonists
- •Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
- •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
研究组 & 干预措施
Pramipexole SR C2B in the fasted state
Experimental
干预措施: Pramipexole SR C2B (Drug)
Pramipexole IR
Active Comparator
干预措施: Pramipexole IR tablets (Drug)
Pramipexole SR C2 in the fasted state
Experimental
干预措施: Pramipexole SR C2 (Drug)
Pramipexole SR C2A in the fasted state
Experimental
干预措施: Pramipexole SR C2A (Drug)
Pramipexole SR C in the fasted state
Experimental
干预措施: Pramipexole SR C (Drug)
Pramipexole SR C2 in the fed state
Experimental
干预措施: High fat, high caloric meal (Other)
Pramipexole SR C2 in the fed state
Experimental
干预措施: Pramipexole SR C2 (Drug)
结局指标
主要结局
AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
时间窗: Up to 30 hours after drug administration
Cmax (maximum measured concentration of pramipexole in blood plasma)
时间窗: Up to 30 hours after drug administration
次要结局
- Number of subjects with clinically significant findings in vital signs(Up to 7 days after last drug administration)
- Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)(Up to 30 hours after drug administration)
- Number of subjects with clinically significant findings in laboratory parameters(Up to 7 days after last drug administration)
- AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),(Up to 30 hours after drug administration)
- tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)(Up to 30 hours after drug administration)
- Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)(Up to 120 hours after drug administration)
- AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)(Up to 30 hours after drug administration)
- λz (terminal rate constant in blood plasma),(Up to 30 hours after drug administration)
- MRTpo (mean residence time of pramipexole in the body after oral administration)(Up to 30 hours after drug administration)
- AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),(Up to 24 hours after drug administration)
- t½ (terminal half-life of pramipexole in blood plasma)(Up to 30 hours after drug administration)
- Number of subjects with adverse events(Up to 7 days after last drug administration)
- CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)(Up to 30 hours after drug administration)
- Number of subjects with clinically significant findings in physical examination(Up to 7 days after last drug administration)
研究者
相似试验
已完成
1 期
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart FailureHeart FailureNCT00891241Lantheus Medical Imaging12
已完成
3 期
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode PsychosisPsychosisNCT00449397AstraZeneca150
已完成
1 期
A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)Parkinson's DiseaseNCT04651153UCB Biopharma SRL62
已完成
1 期
Food Effect and Bioavailability of Deflazacort Formulations in Healthy VolunteersHealthy VolunteersNCT02485431PTC Therapeutics45
已完成
4 期
Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure UnitSeasonal Allergic RhinitisNCT00637611Sanofi1,010