EUCTR2012-001245-40-IT进行中（未招募）不适用
CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)
未提供0 个研究点开始时间: 2013年5月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Population: 60 out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa, will be enrolled to participate into the study. The study will be performed in hospital setting using the facilities of the clinical trial centre in both sites involved in the study. The patients will be recruited within the patient population using the hospitals out-patients clinics. Recruitment timing will be 12 months.
- •Inclusion Criteria:
- •° Subject must be >=30 and <=75 years of age, of either sex and of any race.
- •° Diagnosis of Parkinson's disease
- •° Subjects must be in Hoehn and Yahr stages 2 to 4.
- •° Subject must have good response to levodopa (>=30% improvement in the UPDRS score).
- •° Subject must have been on a stable regimen of L-dopa for at least 4 month before Screening.
- •° A female subject must be postmenopausal, or sterile or use a medically accepted method of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •° Atypical Parkinsonism
- •° Subjects with very severe motor fluctuations and/or dyskinesias.
- •° Significant internal-medicine or psychiatric diseases.
- •° Subject's clinical laboratory tests outside the normal ranges.
- •° History of previous rabdomiolysis.
- •° Subjects in therapy with COMT-inhibitor.
- •° Subjects who participated in any other clinical trial in the 4 months before the screening.
- •° Any subject who is pregnant or breastfeeding.
- •° Subjects demented or not able to give informed consent to trial
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