Study on the pharmacokinetics and bioavailability of compound rifampin tablets in healthy volunteers

Objective:To study the pharmacokinetics and bioavailability of compound rifampin tablets(isoniazid pluss rifampin),using the imported Rifinah tablets as control.Methods:The randomized,cross over study was conducted in 10 healthy volunteers.After a single dose(containing 300 mg isoniazid plus 600mg rifampin),the plasma drug levels were determined by RP HPLC and the pharmacokinetic parameters and relative bioavailability were calculated.Results:The plasma concentration time curves of sample and control were both fitted to a one compartment model.The pharmacokinetic parameters of the sample for isoniazid and rifampin were as follows: T max =(1.50±0.71) and (2.50± 0.53)h; C max =(6.64±2.13) and (9.03±2.12)μg·mL -1 ; t 1/2 =(3.11±1.10) and (4.58±1.21)h; AUC 0～t =(24.07±10.11) and (66.60±18.82)μg·h·mL -1 .The relative bioavailability was (95.9± 23.0)% for isoniazid and (94.1±20.0)% for rifampin.Conclusion:The sample and the control tablets are bioequivalent.