Table 2.
Study schedule and procedures
| 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 |
Before and after sucking