NCT00918177已完成2 期
Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 7
- 主要终点
- To evaluate blood level profiles and safety of the AP09004
研究概览
简要总结
The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects who have participated in another clinical trial within the last 30 days;
- •Subjects with atypical Parkinsonism
- •Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
- •Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
- •Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
- •Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
- •History of drug or alcohol abuse.
- •Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
- •Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.
研究组 & 干预措施
Early patients
Experimental
干预措施: Carbidopa/Levodopa, immediate release (Drug)
Early patients
Experimental
干预措施: AP09004 (Drug)
Moderate Patients
Experimental
干预措施: AP09004 (Drug)
Moderate Patients
Experimental
干预措施: Carbidopa/Levodopa, immediate release (Drug)
结局指标
主要结局
To evaluate blood level profiles and safety of the AP09004
次要结局
- Efficacy of AP09004 on motor scores in Parkinson's patients
研究者
研究点 (7)
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