Abstract
The safety and pharmacokinetics of R50547 nasal spray were assessed by repeated consecutive administration to healthy male volunteers for 11 days or 28 days. There were no abnormalities in terms of the nasal mucosal findings, paranasal X-ray findings, general examination or nasal mucociliary clearance. No adverse reactions were observed in the 11-day treatment, but transient sleepiness was observed in the 28-day treatment. Also, there were some statistically significant changes in laboratory test values such as total protein in the 11-day treatment. However, it was concluded that they did not represent clinical problems as the result of the 28-day treatment. In the pharmacokinetic analysis of the 11-day treatment, no accumulation due to the treatment with R50547 was observed. Based on the above results, the safety of R50547 nasal spray in repeated administration was confirmed.
