Abstract��
OBJECTIVE To evaluate bioequivalence of two paracetamol, dextromethorphan hydrochloride, pseudoephedrine hydrochloride and diphenhydramine hydrochloride tablets in healthy volunteers. METHODS In randomized crossover design, a single dose of test formula and reference formula was given to 20 healthy male volunteers. Dextrorphan, pseudoephedrine and diphenhydramine were measured by LC-MS/MS, paracetamol by HPLC-UV. RESULTS After a single oral administration test formula and reference formula, the main pharmacokinetic parameters of paracetamol were as follows:��max (6.16��1.24) and (6.04��1.03) mg��L-1, tmax (1.31��0.69) and (1.50��0.70)h��AUC0-16 h (29.17��6.67) and (28.76��6.29 )mg��h��L-1. Pharmacokinetic parameters of pseudoephedrine were as follows:��max (210.0��30.3) and (214.6��35.7)��g��L-1��tmax (2.33��1.08) and (2.23��1.19)h��AUC0-24 h (1 887.4��364.3) and (1 936.8��444.3)��g��h��L-1. Pharmacokinetic parameters of diphenhydramine were as follows: ��max (84.4��24.6) and (92.2��29.2)��g��L-1��tmax (2.75��1.11 ) and (2.98��1.06)h��AUC0-36 h (819.2��284.7) and (937.5��391.4) ��g��h��L-1. Pharmacokinetic parameters of dextrorphan were as follows: ��max (6.63��2.90) and (6.00��2.15) ��g��L-1��tmax (2.73��0.92) and (2.58��1.05)h��AUC0-24 h (42.79��13.02) and (40.24��11.92) ��g��h��L-1.The relative bioavailability of paracetamol, pseudoephedrine, diphenhydramine and dextromethorphan were (99.1��9.6)%, (102.7��13.5)%, (114.3��25.3)% and (95.6��17.3)%, respectively. CONCLUSION The results of statistical analysis demonstrated that the two preparations were bioequivalent.
.Pharmacokinetics and Bioequivalence of Paracetamol, Dextromethorphan Hydrochloride, Pseudoephedrine Hydrochloride and Diphenhydramine Hydrochloride Tablets in Healthy Volunteers[J] Chinese Pharmaceutical Journal, 2010,V45(3): 214-217
2010, Vol. 45 
