jRCT2031250157尚未招募不适用
Drug-drug interaction study of OP-2024 with COMT inhibitor (Opicapone) in Healthy Male Volunteers
OHARA Pharmaceuitical Co., Ltd0 个研究点目标入组 20 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
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese male.
- •BMI at time of screening is >= 18.5 to < 25.
- •Written informed consent to participate in this trial can be obtained.
排除标准
- •History of allergies to any component of the investigational product, drug, or food.
- •Subjects with or at risk for angle-closure glaucoma.
- •Subjects with pheochromocytoma or paraganglioma, or other catecholamine-secreting tumors.
- •History of neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
- •History of diseases affecting the gastrointestinal tract, liver, kidneys, or heart that may influence the absorption, distribution, metabolism, or excretion of drugs.
- •History of major surgery involving the gastrointestinal tract, including gastrectomy, gastrostomy, or bowel resection (excluding appendectomy).
结局指标
主要结局
-
Pharmacokinetics
次要结局
未报告次要终点
研究者
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