CTRI/2016/03/006780已完成未知
A Multi-Centre, Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Multiple-Dose, Crossover, Bioequivalence Study of Pramipexole Prolonged Release Tablets 3.15 mg of Mylan Laboratories Ltd., India with Sifrol® 3.15 mg (Pramipexole) depottabletter (depot tablet) of Boehringer Ingelheim International GmbH, Germany in Patients with Idiopathic Parkinsonâ??s disease.
MYLAN LABORATORIES LIMITED INDIA0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 Parkinsonâ??s disease 30 years of age or older at the time of
- •2. Subjects willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests and other study procedures.
- •3. Subjects with a Creatinine clearance > 60 mL/min.
- •4. Patients with Body Mass Index (BMI) greater than or equal to 18.5 but less than or equal to 30.
- •5. Subject should be judged eligible by the principal investigator or co-investigator
- •or physician during a pre-study safety assessment performed within 21 days of
- •the first dose of study medication.
- •6. Signed and dated written informed consent prior to admission to the study in
- •accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and the local regulatory requirements.
排除标准
- •Patients presenting with any of the following will be excluded from the study:
- •1. History of allergy or hypersensitivity reactions to Pramipexole or the ingredients of the formulation. History of lack of efficacy and/or safety events (i.e. adverse event) following use of Pramipexole or the ingredients of the formulation.
- •2. Use of medications that may cause secondary Parkinsonism, including but not
- •limited to: Neuroleptics, Metoclopramide, ô??®-methyldopa, Flunarizine,
- •Methylphenidate, Cinnarizine, Reserpine, or Amphetamines in the last 6 months
- •prior to randomization.
- •3. Signs or symptoms suggesting other Parkinson syndromes (e.g. Atypical
- •parkinsonian syndromes)
- •4. Presence of Dementia by DSM IV criteria or a Mini Mental State Examination score < 24 at Screening Visit
- •5. History of psychosis, except history of drug induced hallucinations
- •6. Clinically significant electrocardiogram (ECG) abnormalities during screening.
- •7. Clinically significant hypotension either at screening visit or at check-in visit.
- •8. Malignant melanoma or history of previously treated malignant melanoma.
- •9. History of epilepsy or psychosis or any other clinically significant disease within the last 1 year of randomization
- •10. Females who are pregnant, breast-feeding, planning to become pregnant or
- •sexually active females of child bearing potential who donâ??t follow contraceptive requirements
- •11. Serum levels of AST (SGOT), ALT (SGPT), alkaline Phosphatase and bilirubin > 2 X Upper Limit of Normal (ULN) (on screening lab test).
- •12. Alcohol or drug abuse (including alcohol), according to Investigatorâ??s judgment, within 6 months prior to screening.
- •13. Consumption of grapefruit, grapefruit-like or grapefruit containing products
- •within 7 days of drug administration.
- •14. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication including but not limited to: Cimetidine, Amantadine,
- •Mexiletine, Zidovudine, Cisplatin, Quinine and Procainamide. They can be
- •allowed depending on Principal Investigatorâ??s discretion in consultation with
- •Medical monitor, if they are kept constant in the last 30 days and are expected to
- •remain constant during the study period
- •15. Subject with a history of difficulty in donating blood or difficulty in accessibility of veins
- •16. Donation or loss of 450 mL or more of blood within 2 months prior to dosing.
- •17. Current history of active systemic bacterial, viral or fungal infections.
- •18. Any clinically significant systemic disease or medical condition that may require treatment or therapeutic intervention during the study.
- •19. Participation in other investigational drug studies or use of other investigational drugs within 30 days prior to randomization.
- •20. Any surgical or medical condition which might significantly alter the
- •absorption, distribution, metabolism, or excretion of study drug
- •21. 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
研究者
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