CTRI/2014/01/004288招募中未知
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 Parkinsonâ??s disease patients
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Subjects with idiopathic Parkinsonâ??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 -1.
- •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 Investigatorâ??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 -1.
- •13.Any other condition or abnormal findings that, in the investigatorâ??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.
- •18.Current history of active systemic bacterial, viral or fungal infections
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