Bioequivalence of acyclovir tablets in healthy volunteers

AIM: To compare the relative bioavailability of the acyclovir preparations: sample tablets and control tablets. METHODS: The acyclovir concentration in 20 healthy young volunteers’ plasma was determined after a single oral dose (400 mg) of sample tablet and control tablet was given separately in an open randomized cross over test. The acyclovir concentration in plasma was assayed by HPLC method and the pharmacokinetic parameters were calculated using 3p97 program by computer. RESULTS: AUC was (4.67±1.01) (μg·h)/L and (4.67±1.19) (μg·h)/L , Tmax was (1.80±0.48) h and (1.75±0.49) h and Cmax was (1.13±0.13) μg/L and (1.12±0.18) μg/L. The relative bioavailability of acyclovir sample tablets compared with the control tablets was 101.3%. The pharmacokinetic parameters of the two preparations had no significant difference by two one-side t test(P0.05). CONCLUSION: The two preparations are bioequivalent.