Screening Day − 7 to − 1 | Day 1 | Day 3 | |
---|---|---|---|
Informed consent | X | ||
Demographical data, medical history and pregnancy test | X | ||
Medical history of dry mouth | X | ||
Physical examination of the oral cavity | X | X | |
Vital signs (blood pressure and pulse rate) | X | X | |
Concomitant diseases and medication/treatment | X | ||
Inclusion and exclusion criteria | X | X | |
VAS assessment of dry mouth | X | X1) | X1) |
Saliva sampling for salivary flow measurement | X | X | |
(1) Unstimulated (baseline measurements) | |||
(2) Rest period (at least 5 min) | |||
(3) Stimulated | |||
Salivary surface tension measurement | X | X | |
Raman spectroscopy (subgroup, n = 6) | X | ||
Tolerability assessment (locally by an investigator and subjective by the subject) | X | X | |
Adverse events and change in concomitant medication | X | X |