Abstract

Aim: Determination of the bioequivalence of 2 clarithromycin tablet formulations manufactured in Korea. Patients and methods: Twenty-four healthy male Korean volunteers received each of the 2 clarithromycin formulations at a dose of 250 mg in a 2 × 2 crossover study. There was a one-week washout period between doses. Plasma concentrations of clarithromycin were monitored by high-performance liquid chromatography over a period of 12 hours after administration. AUCinf (the area under the plasma concentration-time curve from time zero to time infinity) was calculated using 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: The point estimates and 90% confidence intervals for AUCinf (parametric) and Cmax (parametric) were 0.971 (0.886 ~ 1.063) and 0.982 (0.868 ~ 1.107), 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 ~ 0.250). Conclusion: These results indicate that the 2 medications of clarithromycin are bioequivalent and, thus, may be prescribed interchangeably.

Author Details

Authors

• Y.G. Kim¹
• H.J. Kim²
• J.W. Kwon²
• W.B. Kim²
• M.G. Lee¹

Departments

• ¹ College of Pharmacy and Research Institute of Pharmaceutical Sciences, 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, Shinlim-Dong, Kwanak-Gu, Seoul 151-742, Korea

Citation