NL-OMON36833已完成不适用
An open label, crossover study to investigate the safety and tolerability of Sifrol® (pramipexole) (Boehringer Ingelheim) prolonged release tablets in order to establish the maximum tolerable dose and to assess bioequivalence of Pramipexole prolonged release tablets (Synthon B.V.) compared to Sifrol® prolonged release tablets (Boehringer Ingelheim) in healthy subjects in steady-state conditions - CT.PAL.mrt.45.12.001
Synthon B.V0 个研究点目标入组 52 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
- 52
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. Healthy, non-smoking, non-vegetarian, Caucasian male volunteers, 18 - 55 years of age, inclusive.;2. Body Mass Index (BMI) that is within 18.5-30.0 kg/m², inclusive.;3. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by Principal Investigator/Sub-Investigator.;4. Supine blood pressure between 90-150 mm Hg, inclusive, systolic and 50-90 mm Hg, inclusive, diastolic and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the Principal Investigator/Sub-Investigator. ;Refer to protocol for a complete list of the inclusion criteria.
排除标准
- •1. Known history or presence of any medical conditon determined as clinically significant by Principal Investigator/Sub-Investigator.;2. Out of range creatinine clearance in plasma according to Cockroft and Gault.;3. Known history or presence of drug or alcohol abuse, any relevant history of sleep disorder, food allergies ;Refer to protocol for a complete list of the inclusion criteria
研究者
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