Objective To study the absorption and biologic effects of the buccal spray insulin preparation in healthy volunteers. Methods
In this open, single-center, euglycemic insulin clamp study, after a baseline period of 2 hours, 13 healthy vollunteers (11 men, 2 women), aged (24.2±2.3)years with body mass index (20.7±2.0)kg/m 2 received the buccal spray insulin
administration of single dosage of 40 U. After administration, the blood samples at 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 min were taken for serum insulin measurement. Meanwhile, glucose infusion rates (GIR) were determined per 5 minutes over a period of 6 hours, and the parameters of pharmacokinetics and
pharmacodynamics were calculated. Results The insulin profile manifested three peak values in each subject after administration, the group data showed that C max (mU/L) were 12.2±6.8, 15.2±6.3 and 16.5±8.1, T Cmax (min) were 45.0±17.7, 128.8±26.7 and 270.0±42.4. The pharmacodynamics presented similar profile that ΔGIR max (mg·kg -1 ·min -1 ) above baseline level were 2.75±1.97, 4.40±1.99 and 4.38±1.45, T ΔGIRmax (min) were 79.2±30.9, 170.0±42.9 and 281.5±35.6. Conclusion The results show that the action onset time is about one hour after administration, and the action lasts more than 4 hours.