Bioequivalence assessment of closerin capsule to Dura seromycin capsule ofcycloserine after a single oral dose administration to healthy male volunteers

Aim: A bioequivalence study of the closerin capsules to the dura seromycin capsules was conducted. Patients and methods: Twenty-four healthy male Kore an volunteers received each medicine at the cycloserine dose of 250 mg in a 2 x 2 crossover study. There was a one-week washout period between the dos es. Plasma concentrations of cycloserine were monitored by a high-performan ce liquid chromatography for over a period of 72 hours after the administra tion. AUC(inf) (the area under the plasma concentration-time curve from tim e zero to time infinity) was calculated by the linear-log trapezoidal metho d. C-max (maximum plasma drug concentration) and T-max (time to reach C-max ) were compiled from the plasma concentration-time data. Analysis of varian ce was carried out using logarithmically transformed AUC(inf) and C-max, an d untransformed T-max. Results: There were no significant differences betwe en the medications in AUC(inf) and C-max. The point estimates and 90% confi dence intervals for AUC(inf) (parametric) and C-max (parametric) were, in p oint estimate (90% confidence interval), 0.992 (0.950 similar to 1.037) and 1.051 (0.965 similar to 1.144), respectively, satisfying the bioequivalenc e criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value of T-max was 0.000 (-0.250 similar to 0.125). Moreover, the modified Pitman-M organ's adjusted F test and equal variance test (one-sided) indicated that the 2 medications were comparable in intra- and inter-individual variabilit y in cycloserine bioavailability. Conclusion: Therefore, these results indi cate that the 2 medications of cycloserine are bioequivalent and, thus, may be prescribed interchangeably.