EUCTR2006-005291-41-AT
Active, Not Recruiting
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10006440Term: Bronchial obstruction
- Sponsor
- CYATHUS Exquirere PharmaforschungsGmbH
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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