Abstract��
OBJECTIVE: To compare the pharmacokinetics and evaluate the bioequivalence of the domestic and imported ambroxol (Amb) hydrochloride tablets. METHODS: 8 healthy subjects were enrolled in a randomized crossover study with a single oral dose of 90 mg of the two formulations respectively.Plasma concentrations of Amb were determined by HPLC.Aera under the drug concentrationtime curve (AUC0��24) was evaluated by variance analysis and two one+sided t-test. RESULTS: A two-compartment open pharmacokinetic model was adopted in Amb plasma concentration-time data analysis.The peak concentrations of Amb(cmax) were (200.57��
25.30)ng��ml-1 and (201.64��
23.89)ng��ml-1,time to reach the peak concentrations (tmax) (1.31��0.26)h and (1.38��0.23)h,the elimination half life (t1/2) (7.22��1.50)h and (7.86��1.77)h,AUC0��24 (1225.03��182.32) and (1229.60��276.51) (h��ng��ml-1),respectively in the domestic and imported tablets. CONCLUSION: The two formulations were of bioequivalence.The relative bioavailability of the domestic tablet was (101.22��10.25)%
Li Zhen,
Li Zhen
.Bioequivalence evaluation of domestic ambroxol hydrochloride tablets in healthy subjects[J] Chinese Pharmaceutical Journal, 1999,V34(08): 541-543
1999, Vol. 34 
