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Bioequivalence of Topamin Tablet to Topamax Tablet (Topiramate 100 mg)

토파맥스 정(토피라메이트 100mg)에 대한 토파민 정의 생물학적동등성

  • Published : 2008.08.20

Abstract

The purpose of the present study was to evaluate the bioequivalence of two topiramate tablets, Topamax tablet (Janssen Korea. Co., Ltd., Seoul, Korea, reference drug) and Topamin tablet (Myungmoon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet at the dose of 100 mg topiramate in a $2{\times}2$ crossover study. There were two-weeks washout period between the doses. Plasma concentrations of topiramate were monitored by an LC-MS/MS for over a period of 96 hr after administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 96 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$, ratio and the $C_{max}$ ratio for Topamin/Topamax were $\log0.88{\sim}\log1.02$ and $\log0.87{\sim}\log1.03$, respectively. These values were within the acceptable bioequivalence intervals of $\log0.80{\sim}\log1.25$. Taken together, our study demonstrated the bioequivalence of Topamax and Topamin with respect to the rate and extent of absorption.

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References

  1. H.D. Langtry, J.C. Gillis and R. Davis, A review of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in the management of epilepsy, Drugs, 54, 752-773 (1997) https://doi.org/10.2165/00003495-199754050-00009
  2. W.E. Rosenfeld, Topiramate: a review of preclinical, pharmacokinetic, and clinical data, Clin. Ther., 19, 1294- 1308 (1997) https://doi.org/10.1016/S0149-2918(97)80006-9
  3. M. Britzi, E. Perucca, S. Soback, R.H. Levy, C. Fattore, F. Crema, G. Gatti, D.R. Doose and B.E. Maryanoff, Pharmacokinetic and metabolic investigation of topiramate disposition in healthy subjects in the absence and in the presence of enzyme induction by carbamazepine, Epilepsia, 46, 378-384 (2005) https://doi.org/10.1111/j.0013-9580.2005.55204.x
  4. E. Perucca and M. Bialer, The clinical pharmacokinetics of the newer antiepileptic drugs. Focus on topiramate, zonisamide and tiagabine, Clin. pharmacokinet., 31, 29-46 (1996) https://doi.org/10.2165/00003088-199631010-00003
  5. 식품의약품안전청 고시 제 2002-60호, 생물학적동등성시험기준 (2005. 06. 07)
  6. 식품의약품안전청 고시 제 1999-67호, 의약품임상시험관리기준 (2000. 01. 04)