MedDRA version: 8.1 Level: LLT Classification code 10006440 Term: Bronchial obstruction
Conditions
Interventions
Product Name: Ambroxol “CYATHUS” 50 mg/mL Oral Spray
Pharmaceutical Form: Oral solution
INN or Proposed INN: AMBROXOL HYDROCHLORIDE
CAS Number: 23828924
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
CYATHUS Exquirere PharmaforschungsGmbH
Eligibility
Sex/Gender
Male
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess pharmacokinetic data of a new galenic formulation of an Ambroxol Spray, Ambroxol “CYATHUS” 50 mg/mL Oral Spray, in healthy male volunteers, using a single dose of 30 mg Ambroxol-Hydrochloride per period. The primary parameters for evaluation will be the area under the concentration-time curve between time 0 and 6 hours (AUC0-6), the peak concentration (Cmax) and the time of the peak concentration (tmax). To compare, in a descriptive way, the results with those of a previous study (cf. 5.2). To evaluate the results, in a descriptive sense, for planning and sample size calculation of a confirmative Bioequivalence study, using Ambroxol “CYATHUS” 50 mg/mL Oral Spray as Test formulation and Mucosolvan 15 mg/5 mL Saft (Boehringer Ingelheim, Austria) as reference formulation. ;Secondary Objective: To compare, in a descriptive way, different modes of oral application of Ambroxol “CYATHUS” 50 mg/mL Oral Spray with respect to mean, standard deviation and CI of pharmacokinetic parameters. The different modes of applications are: Application lingual, drinking a cup of water immediately after application, Application lingual, drinking a cup of water 30 minutes after application, Application buccal, drinking a cup of water immediately after application, Application buccal, drinking a cup of water 30 minutes after application, Application near pharyngeal area, drinking a cup of water 30 minutes after application. To select the optimal time points for blood samples for a confirmatory study. ;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed