EUCTR2006-005291-41-AT进行中（未招募）不适用
A single center, open, pilot study to evaluate the pharmacokinetic profile of a new galenic formulation of an Ambroxol-Hydrochloride (Ambroxol-HCl) spray: Ambroxol CYATHUS” 50 mg/mL Oral Spray, administered in a single dose of 30 mg Ambroxol-HCl to healthy male volunteers
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
- Male
入选标准
- •age between 19 and 50 years
- •able to participate in the entire study
- •healthy, male volunteer
- •Body mass index (BMI) within a range of 21-28
- •signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •known contraindications to Ambroxol
- •subject is mentally not capable of adhering to the protocol
- •known allergic reactions to one of the compounds of the study medication or related compounds
- •suffering from depression or other psychological disorders
- •impaired kidney, liver, or lung function
- •cardiac malfunction
- •hypertension: Diastolic Blood Pressure (DBP) >90 mm Hg or Systolic Blood Pressure (SBP) > 140 mm Hg
- •hypotension: Systolic Blood Pressure <100 mm Hg
- •bradycardia (frequency <45)
- •gastrointestinal disorders, especially ulcers and acute or chronic gastritis
- •pathological findings of blood analysis, especially agranulocytosis
- •pathological changes in the oral cavity
- •diabetes mellitus
- •subjects currently suffering from acute infections
- •drug addiction, positive drug-screening
- •nicotine: more than 10 cigarettes/ day
- •alcoholism
- •positive HIV-screening
- •any use of medication during two weeks previous to study onset
- •subjects having participated in another study four weeks previous to study onset
- •blood loss of more than 500 mL eight weeks previous to study onset
研究者
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