The clinical pharmacokinetics and bioequivalence of benzoylmetronidazole capsules
- Author:
Jian-Shi LOU
1
Author Information
1. Dept. of Clinical Pharmacology, Tianjin Medical University
- Publication Type:Journal Article
- Keywords:
Benzoylmetronidazole;
Bioequivalence;
Pharmacokinetics;
Volunteers
- From:
Chinese Pharmacological Bulletin
2002;18(1):73-76
- CountryChina
- Language:Chinese
-
Abstract:
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 Tmax(5.10 ± 1.60) h and (3.12 ± 0.90) h; Cmax(5.32 ± 0.87) mg·L-1 and (6.51 ± 1.25) mg·L-1; T1/2(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 Tmaxand Cmax(P<0.05). The relative bioavailability of benzoylmetronidazole capsule is (95.07 ± 14.70) %. The AUC between the two formulations is bioequivalent, but the Tmax and Cmax are non-bioequivalent.
