Earticle

초록

영어

Fexofenadine, one of selective histamine receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet made by Hanmi Pharm. Co. and the reference product was Allegra Tablet made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, , were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of were log 1.149 and log 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

목차

영문초록
 실험재료및 방법
 실험결과 및 고찰
 결 론
 감사의 말씀
 참고문헌

키워드

저자

• 고인자 [ In-Ja Ko | 성균관대학교 약학부 ]
• 이엔티엔하이 [ Thien Hai | 성균관대학교 약학부 ]
• 지상철 [ Sang-Chol Chi | 성균관대학교 약학부 ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615