For this study healthy volunteers will be recruited. The test product (Posterisan corte Placebozäpfchen) is a placebo that containes no active substance. MedDRA version: 9.1 Level: LLT Classification code 10022725 Term: Intolerance induced
Conditions
Interventions
Product Name: Posterisan corte Placebozäpfchen
Pharmaceutical Form: Suppository
Sponsors
Dr. Kade Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers 18 years of age or older with capacity to 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - diseases and/or irritations in the anal region, specifically the anal canal and the rectum. - known hypersensitivity to the ingredients - known or suspected drug or alcohol abuse - pregnant and breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Incidence of all intolerances;Secondary Objective: Assessment of tolerance by the physician Assessment of tolerance by the tested subjects;Primary end point(s): Incidence of intolerances | — |
Countries
Germany
Outcome results
None listed