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
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10006440Term: Bronchial obstruction
- Registration Number
- EUCTR2006-005291-41-AT
- Lead Sponsor
- CYATHUS Exquirere PharmaforschungsGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method