Pharmacokinetic study of fudosteine in healthy volunteers

Aim: To study the pharmacokinetics of oral administration of fudosteine in healthy volunteers. Methods: 36 healthy volunteers were randomly grouped into three pools, each of with consisted of 12, and were orally given 600, 400, and 200 mg of fudosteine tablets in a single of multiple modes. After plasma sampling, plasma concentration of fudosteine were determined by HPLC equipped with a fluorescence detector. Results: For the groups receiving 600, 400, and 200 mg in a single mode, c_max were found to be (22.44 ± 7.61), (12.91 ± 2.93), (6.53 ± 1.61) μg/mL; t_max were (0.52 ± 0.37), (0.44 ± 0.15), (0.40 ± 0.21)h. Following oral dosing of 400 mg of fudosteine tablets in multiple modes, c_max and t_max were found to be (13.64 ± 4.39) μg/mL, (0.55 ± 0.50)h respectively. And c_ss was estimated to be (3.67 ± 0.95) μg/mL. After co-administration of 200 mg of fudosteine tablet with a meal, c_max was found to be (3.37 ± 0.68) μg/mL and t_max was (1.40 ± 0.78)h. Conclusion: For the three groups given three doses of fudosteine, pharmacokinetics parameter such as t_max, K, t_1/2, MRT were similarly. However, both magnitudes of c_max and AUC_0-τ were dose-dependent. Mode of administration didn't result in significant difference in the pharmacokinetic parameters(P > 0.05). Moreover, parameters, c_max and t_max, had significant difference between the fasting and fed groups (P < 0.01).