Pharmacokinetics and relative bioavailability of ribavirin in Chinese healthy volunteers

AIM: To study the pharmacokinetics and bioavailability of ribavirin in 18 young healthy volunteers. METHODS: The ribavirin concentrations in plasma were determined by HPLC after a single oral dose of the standard formulation and the tested formulation which were respectively given to 18 volunteers in randomized cross-over test. RESULTS: The concentration-time curves of three formulations fitted to one-compartment open model. The C_ max were 0.76 ± 0.37 , 0.72 ± 0.22 and 0.76 ± 0.40 mg·L -1 ; T_ max were 2.07 ± 0.89 , 1.67 ± 0.49 and 1.86 ± 0.41 h ; T_ 1/2ke was 22±3, 24±4 and 22± 4 h ; AUC t_0 were 12±4, 14±4 and 12±4 mg·h·L -1 ; and AUC ∞_0 were 16±5, 18±5 and 15±5 mg·h -1 ·L -1 in a standard formulation and two tested formulations, respectively. The pharmacokinetic parameters showed no significant difference among three formulations (P 0.05 ). The relative bioavailability of two tested formulations was (112±21) % and (100±18)%. CONCLUSION: The two tested formulations are bioequivalent with referenced formulation.