Abstract: AIM:To compare the pharmacokinetics and relative bioequivalence of chewable tablet of clindamycin palmitate hydrochloride with that of dispersible tablet. METHODS:An open randomized and two-period crossover study with a one week washout interval was performed in 20 healthy volunteers. Concentrations of clindamycin in plasma were assayed by High Performance Liquid Chromatography method after a single oral dose of 600 mg of the tested or the reference tablets. RESULTS:Limit of quantification was accepted as 0.125 μg/mL (r =0. 999). The main pharmacokinetic parameters of the test and the reference formulations were as follows: C_max were (4. 5 ±1. 4) and (4. 6 ±1. 4) μg/mL;t_max were (0. 83 ±0. 33) and (0. 90 ±0. 29) h; t_1/2 were (2. 3 ±0. 7) and (2. 3 ±0. 7) h; AUC_0→t were (16 ±6) and (17 ±6) μg·mL^-1·h; AUC_0→∞ were (17 ±6) and (18 ±6) μg·mL^-1·h. There was no significant difference between the parameters of two tablets. CONCLUSION: The relative bioavailability of the test tablet to reference tablet was 96. 3% .The results of the statistical analysis show that the two formulations are bioequivalent.

Key words: clindamycin, bioequivalence, HPLC