E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006440 |
E.1.2 | Term | Bronchial obstruction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Pilot Study for Bioequivalence |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 70 |