Bioequivalence of salbutamol orally disintegrating tablet in healthy subjects

Objective:To study the relative bioavailability and pharmacokinetics of salbutamol orally disintegrating tablet in 18 healthy male volunteers.Methods:A single dose of 8 mg of salbutamol orally disintegrating tablet was administered in a randomized crossover way in 18 volunteers and the plasma concentrations of salbutamol were determined by HPLC.The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioavailability was evaluated.Results:The concentration-time curve of two preparations fitted two compartment model.The peak plasma levels(cmax) of salbutamol orally disintegrating tablet and market of salbutamol were 17.48±5.52 and 16.60±6.21 ng/ml,respectively.The peak time(Tmax) were 2.47±1.04 and 2.03±1.17h and AUC(0-24) were 127.34±32.66 and 131.42±37.73 ng·h/ml,respectively,The relative bioavailability of salbutamol orally disintegrating tablet was 98.76%±12.92%.Conclusion:The results of two one-side tests suggest that salbutamol orally disintegrating tablet is bioequivalent to the market tablet of salbutamol.