Pharmacokinetic interaction between bencycloquidium bromide nasal spray and budesonide nasal spray in healthy volunteers

The pharmacokinetic interaction between bencycloquidium bromide nasal spray(BCQB)and budesonide nasal spray(BUD)in human was investigated. 12 male volunteers were randomly divided into two groups according to an open, randomized, two-period, two-way crossover design. In period 1, Group I took single dose BCQB 180 μg, multiple doses BCQB(180 μg, four times daily for 6 days)and combined dose(BCQB 180 μg and BUD 256 μg); Group II took single dose BUD 256 μg, multiple doses BUD(256 μg, once daily for 7 days)and combined dose(BCQB 180 μg and BUD 256 μg), successively. After a wash-out time of 7 days, the two groups exchanged their administration processes in period 2. Plasma concentration of bencycloquidium bromide and budesonide were measured by LC-MS/MS, respectively. The pharmacokinetic parameters, c_max, AUC and t_max, were calculated and statistically analyzed. Results showed that there was no obvious pharmacokinetic interaction between BUD and BCQB when they were administered jointly to healthy volunteers.