CTRI/2014/01/004288招募中不适用
A multi-centre randomized, open-label, two treatment, two sequence, crossover study to evaluate the bioequivalence of Pramipexole dihydrochloride Extended Release Tablets (2.25 mg and 4.5 mg) of Mylan Laboratories Ltd., India compared to Sifrol® ER Tablets (2.25 mg and 4.5 mg) of Boehringer Ingelheim International GmbH, in Parkinson’s disease patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- To characterize the pharmacokinetic profiles of Pramipexole at steady state under fasting condition and to study the effect of food in steady state under fed condition following once daily administration of PPX ER 2.25 mg and 4.5mg tablets and also to assess the bioequivalence of Pramipexole between the Test product and Reference product at steady state in fed and fasting conditions.
研究概览
简要总结
Multicenter, randomized, open-label, two treatment, twosequence, crossover bioequivalence study of Pramipexole dihydrochlorideExtended Release Tablets (2.25 mg and 4.5 mg) inParkinson’s disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •2.Subjects 30 years of age or older at the time of diagnosis.
- •3.Subjects already receiving pramipexole 2.25 mg as total daily dose either as immediate release formulation or extended release formulation for Part A of the study and Patients already receiving pramipexole 4.5 mg as total daily dose either as immediate release formulation or extended release formulation for Part B of the study 4.Subjects eligible to receive 2.25 mg with respect to his current clinical condition as per principal investigators discretion will be enrolled in Part A of the study and patients eligible to receive 4.5 mg with respect to his current clinical condition as per principal investigators discretion will be enrolled in Part B of the study 5.Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •6.Subjects with a Creatinine clearance > 60 mL/min.
排除标准
- •1.Clinically relevant abnormal vital sign values or safety laboratory data.
- •2.History of psychosis, except history of drug induced hallucinations 3.Clinically significant electrocardiogram (ECG) abnormalities.
- •4.Clinically significant hypotension either at screening visit or at visit, Day -
- •5.Malignant melanoma or history of previously treated malignant melanoma.
- •6.Any other clinically significant disease 7.Pregnancy or breast-feeding.
- •8.Sexually active female of childbearing potential 9.Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline Phosphatase and bilirubin > 2 Upper Limit of Normal (ULN) (on screening lab test).
- •10.Known hypersensitivity to Pramipexole or its excipients.
- •11.Drug abuse (including alcohol), according to Investigator’s judgment, within 2 years prior to screening.
- •12.Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to visit, Day -
- •13.Any other condition or abnormal findings that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study 14.Subject with a history of difficulty in donating blood or difficulty in accessibility of veins 15.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
- •16.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
- •17.Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
结局指标
主要结局
To characterize the pharmacokinetic profiles of Pramipexole at steady state under fasting condition and to study the effect of food in steady state under fed condition following once daily administration of PPX ER 2.25 mg and 4.5mg tablets and also to assess the bioequivalence of Pramipexole between the Test product and Reference product at steady state in fed and fasting conditions.
时间窗: Baseline to End of Study
次要结局
- To assess the safety and tolerability of PPX ER 2.25 mg and 4.5mg tablets following once daily oral administration at steady state under fasting and fed condition.(Baseline to End of Study)
研究者
研究点 (7)
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