NL-OMON50655已完成不适用
A NON-RANDOMIZED, OPEN-LABEL, CROSS-OVER, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF BIA 28-6156 AT STEADY-STATE ON THE PHARMACOKINETICS OF LEVODOPA/CARBIDOPA AND LEVODOPA/BENSERAZIDE IN HEALTHY SUBJECTS. - BIA 28-6156 & L-Dopa plus Carbidopa or Benserazide DDI in healthy subjects
BIAL R&D INVESTMENTS, S.A.0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Sex: Male or female; females must be of nonchildbearing potential or
- •postmenopausal.
- •2. Age: 18 to 75 years, inclusive, at time of consent.
- •3. Body mass index: 18.0 to 32.0 kg/m2, inclusive, at screening.
- •4. Weight: >=50 kg at screening.
- •5. Status : Healthy subjects.
- •+ Further criteria apply.
排除标准
- •1. Employee of PRA Health Sciences (PRA) or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) within 2 years prior to the first drug administration in the
- •current study.
- •4. Using tobacco or nicotine products within 14 days prior to the first drug
- •administration in the current study.
- •5. History of liver disease, previous bone marrow depression, hypersensitivity
- •to levodopa/carbidopa, or hypersensitivity to levodopa/benserazide.
- •+ Further criteria apply.
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