Study on healthy male subjects
Conditions
Interventions
Group 1: Administration of one spray of AM-301 into each nostril (0.14 mL - Group A).
Group 2: Administration of two sprays of AM-301 into each nostril (2x 0.14 mL - group B).
Group 3: Administration
Sponsors
Altamira Medica AG
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • Healthy, non-smoking male, with age from 18-50 years. • Body Mass Index (BMI) of 18.0-25.0 kg/m2;
Exclusion criteria
Exclusion criteria: Main exclusion criteria: • Any clinically relevant nasal obstruction or pathology precluding effective and/or efficient intranasal delivery (controlled by endoscopy of the nasal cavity). • Any treatment with nasal treatments within 30 days prior to the assessment visit (including nasal spays, nasal drops and saline washes). • Any clinically relevant medical history or concomitant medication, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal residence time defined as time from application to the disappearance of test product from the middle and inferior turbinates. Distribution of stained test product within nasal cavity will be evaluated (presence “intense”, “moderate”, “minimal” or “absent” at anterior end of middle and inferior turbinate) at 1, 5, 10, 20, 30, 45, 60 minutes, then every 30 minutes until up to 240 minutes, or until no more stained test product visible following application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from application to the observed appearance of a broad stained front in the oropharynx for 10 minutes. | — |
Countries
Germany
Contacts
Public ContactViola Wierschin
Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde
Outcome results
None listed