Bioequivalence evaluation of secnidazole tablets in healthy male volunteers
- VernacularTitle:塞克硝唑片剂健康人体生物等效性研究
- Author:
Shaojun SHI
;
Zhongfang LI
;
Yuansheng WAN
;
Huating CHEN
;
Fandian ZENG
- Publication Type:Journal Article
- Keywords:
secnidazole tablets;
HPLC;
pharmacokinetics;
bioavailability;
bioequivalence
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2007;12(1):98-102
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To compare the bioavailability of the test and reference formulation of secnidazole (2 g) tablets under fasting conditions. METHODS: This bioequivalence study was carried out in 20 healthy male Chinese volunteers according to a single dose, two-sequence, crossover randomized design. Fifteen blood samples per period were collected over 96 h, and plasma secnidazole concentrations were determined by locally validated high performance liquid chromatography (HPLC) assay and pharmacokinetic parameters were analyzed by the non-compartmental and compartmental methods. RESULTS: Plasma concentration-time profiles were adequately described by a one-compartment open model with first-order absorption. The main pharmacokinetic parameters of secnidazole test and reference tablets were as follows: tmax were (2.30±1.06) and (2.28±1.10) h, Cmax were (49.63±6.35) and (46.17±4.24) mg/L, t1/2 were (28.84±3.41) and (29.05±4.01) h, AUC0-96 were (1832.06±180.15) and (1847.14±204.14) mg·h-1·L-1, respectively. The relative bioavailability of test tablets was (99.99±11.92)%. CONCLUSION: The results indicate that the two formulations of secnidazole tablets are bioequivalent in the rate and extent of absorption.
