Bioequivalence assessment of closerin capsule to Dura seromycin capsule of cycloserine after a single oral dose administration to healthy male volunteers
Y.G. Kim1, Y.J. Lee1, E.D. Lee2, S.D. Lee2, J.W. Kwon2, W.B. Kim2 C.-K. Shim1, M.G. Lee1
1 College of Pharmacy, Seoul National University, and 2 Research Laboratory, Dong-A Pharmaceutical Company, Yongin, Korea
DOI 10.5414/CPP38461
Abstract
Aim: A bioequivalence study of the closerin capsules to the dura seromycin capsules was conducted. Patients and methods: Twenty-four healthy male Korean volunteers received each medicine at the cycloserine dose of 250 mg in a 2 × 2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of cycloserine were monitored by a high-performance liquid chromatography for over a period of 72 hours after the administration. AUCinf (the area under the plasma concentration-time curve from time zero to time infinity) was calculated by the linear-log trapezoidal method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCinf and Cmax, and untransformed Tmax. Results: There were no significant differences between the medications in AUCinf and Cmax. The point estimates and 90% confidence intervals for AUCinf (parametric) and Cmax (parametric) were, in point estimate (90% confidence interval), 0.992 (0.950 ~ 1.037) and 1.051 (0.965 ~ 1.144), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value of Tmax was 0.000 (–0.250 ~ 0.125). Moreover, the modified Pitman-Morgan’s adjusted F test and equal variance test (one-sided) indicated that the 2 medications were comparable in intra- and inter-individual variability in cycloserine bioavailability. Conclusion: Therefore, these results indicate that the 2 medications of cycloserine are bioequivalent and, thus, may be prescribed interchangeably.
Author Details
Authors
Departments
- 1 College of Pharmacy, Seoul National University, and
- 2 Research Laboratory, Dong-A Pharmaceutical Company, Yongin, Korea
Address
Dr. M.G. Lee; College of Pharmacy, Seoul National University, San 56-1, Shinrim-Dong, Kwanak-Gu, Seoul 151-742, Korea
Citation
Y.G. Kim, Y.J. Lee, E.D. Lee, S.D. Lee, J.W. Kwon, W.B. Kim C.-K. Shim and M.G. Lee.Bioequivalence assessment of closerin capsule to Dura seromycin capsule of cycloserine after a single oral dose administration to healthy male volunteers. 2000; 38: 461-466. doi: 10.5414/CPP38461.
