Abstract: AIM: To evaluate the bioequivalence of Clarithromycin soft capsule in healthy Chinese volunteers. METHODS: A single oral doses of 0.25 g Clarithromycin soft capsule and tablet(test and reference) were given to 20 healthy volunteers according to an open randomized crossover design.The concentrations of Clarithromycin in plasma were determined by LC-MS/MS.With the aid of BAPP2.0,the bioequivalence of the test and reference preparation were calculated by analysis of variance,tow one sided t-test. RESULTS: The pharmacokinetic parameters of the two preparations were as follow: t_max of test drug and reference drug were (2.1±0.6)、(2.0±0.8)h, C_max were(815±191)、(800±200) ng/mL, t_1/2 were(4.0±0.4)、(3.9±0.5) h, AUC_0-24 were (5612±1283)、(5246±1375) ng·h·mL^-1, AUC_0-∞ were (5722±1313)、(5339±1402) ng·h·mL^-1, respectively. The relative bioavailability of the test formulation were (110.5±23.9)%. CONCLUSION: The tested preparation was of bioequivalence to the reference preparation.

Key words: Clarithromycin, LC-MS/MS, Soft capsule, Pharmacokinetics, Bioequivalence