The clinical pharmacokinetics and bioequivalence of benzoylmetronidazole capsules

AIM To compare the pharmacokinetics and bioequivalence of between capsule and solution of benzoylmetronidazole. METHODS Ten chinese healthy male volunteers in a randomized 2-way crossover study were given a single oral dose 960 mg capsule(test) and solution (control) respectively. The serum concentrations of metronidazole, one of the metabolites of benzoylmetronidazole, was measured by high performance liquid chromatography. RESULTS The serum concentration-time curves appeared one-compartment open model. The results of the capsule and the solution of benzoylmetronidazole showed that T max (5.10±1.60) h and (3.12±0.90) h; C max (5.32±0.87) mg·L -1 and (6.51±1.25) mg·L -1 ; T 12 (10.56±1.75) h and (10.16±1.65) h; AUC (106.96±19.62) mg·h -1 ·L -1 and (113.59±19.84) mg·h·L -1 . CONCLUTION No significant difference appears in the pharmacokinetic parameters between the two formulations except of T max and C max ( P 0.05). The relative bioavailability of benzoylmetronidazole capsule is (95.07±14.70)%. The AUC between the two formulations is bioequivalent, but the T max and C max are non-bioequivalent.