Bioequivalence study of two crystal forms of rifampicin in isoniazid and rifampicin tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the pharmacokinetic properties and bioequivalence of two crystal forms of rifampicin. METHODS: Drawing the dissolution curves of reference and test medicines in different solutions, and calculated the value of f2. Twenty-nine healthy male volunteers were randomly administered in a crossover single 300 mg dose of reference and test medicines. Determining the concentration of rifampicin in plasma by HPLC-MS, and analyzed the relative bioavailability and bioequivalence of tablets using SAS program. RESULTS: The values of f2 were more than 50.The pharmacokinetic properties of reference and test tablets were as follows AUC0→t (28476±8 050) vs (28120±6916) ng·mL·h-1, ρmax (5552±1554) vs (5911±1700)ng·mL-1, t2 (2.0±1.0) vs (1.8±1.0) h, t1/2(2.8±0.5)vs(2.8±0.5) h. 90% CI of AUC and ρmax of test medicine were 96.2%-106.4% and 98.6%-115.3%, respectively. And there were no significant difference of the tmax of rifampicin between the two medicines (P>0.05). CONCLUSION: The results indicate that the two medicines made from rifampicin two crystal forms are bioequivalent completely.