Biomolecules & Therapeutics

The Korean Society of Applied Pharmacology (한국응용약물학회)
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Bioequivalence Assessment of Triamcinolone Tablets in Healthy Male Human Volunteers

  • Pyo, Hee-Soo (Toxicology Lab., Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology) ;
  • Jang, Moon-Sun (Toxicology Lab., Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology) ;
  • Chung, Youn-Bok (College of Pharmacy, Chungbuk National University) ;
  • Kwon, Oh-Seung (Toxicology Lab., Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology)
  • Published : 2002.09.01
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Abstract

The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang Triamcinolone$\textregistered$ vs. Wyeth Korea Ledercoat$\textregistered$) was assessed in healthy male volunteers after oral administration of 16mg triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0\longrightarrowlast}$, $AUC_{0\longrightarrowinf}$ and $T_{1/2, \beta} were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to Korea Food and Drug Administration Guideline. The analysis of variance did not show any significant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang triamcinlone$\textregistered$ tablet is bioequivalent to the Wyeth Korea Ledercoat$\textregistered$ tablet.

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