액토스정®(피오글리타존 30 mg)에 대한 염산피오글리타존정의 생물학적동등성Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg)
- Authors
- 염혜선; 이태호; 염정록; 송진호; 한상범
- Issue Date
- Feb-2009
- Publisher
- 한국분석과학회
- Keywords
- pioglitazone; bioequivalence; LC-MS/MS; analytical validation
- Citation
- 분석과학, v.22, no.1, pp 101 - 108
- Pages
- 8
- Journal Title
- 분석과학
- Volume
- 22
- Number
- 1
- Start Page
- 101
- End Page
- 108
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/32675
- ISSN
- 1225-0163
2288-8985
- Abstract
- 다케다약품공업주식회사의 “액토스정<SUP>®</SUP> 30 ㎎”을 대조약으로 하고 보령제약주식회사의 “염산피오글리타존정 30 ㎎”을 시험약으로 하여, 2×2 교차시험법에 따라 지원자 28 명을 대상으로 생물학적동등성시험을 실시하였다. 이를 위하여 피오글리타존 30 mg을 각 지원자에게 경구 투여한 후, 0-36 시간동안 채혈한 혈장 시료를 확보하였다. 혈장 중 피오글리타존을 분석하기 위하여, LC-MS/MS 분석법을 확립하였으며 분석결과의 신뢰성을 높이기 위하여 분석법 검증을 수행하였다. 그 결과, 5-2000 ng/mL의 농도범위에서 우수한 직선성을 나타내었으며, 생물학적동등성시험에 이용될 수 있는 충분한 감도와 특이성, 정밀성 및 정확성을 확인하였다. 각 피험자들의 혈중 약물농도 데이터로부터 구한 혈중약물농도-시간곡선하면적(AUC<SUB>t</SUB>)과 최고혈중농도(C<SUB>max</SUB>) 등의 약물속도론적 파라미터에 대해 통계학적으로 고찰한 결과, 판정기준을 만족 시켰으며, 따라서 두 제제는 생물학적으로 동등한 것으로 평가하였다.
The bioequivalence of two pioglitazone tablets, Actos<SUP>®</SUP> tablet (Takeda Chemical Industries, reference drug) and Pioglitazone tablet (Boryung Company, test drug) was evaluated according to the guidelines of Korea Food and Drug Administration. Twenty-eight healthy male Korean volunteers received each medicine (pioglitazone dose of 30 mg) in a 2×2 crossover study with one week washout interval. After drug administration, blood samples were collected at specific time intervals from 0-36 hours. The plasma concentrations of pioglitazone were determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The total chromatographic run time was 5 min and calibration curves were linear over the concentration range of 5-2000 ng/mL for pioglitazone. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations. The 90% confidence intervals of the AUCt ratio and the C<SUB>max</SUB> ratio for Pioglitazone tablet and Actos<SUP>®</SUP> tablet were log0.9422~log1.1040 and log0.9200~log1.1556, respectively. Based on the statistical considerations, we can conclude that the test drug, Pioglitazone tablet was bioequivalent to the reference drug, Actos<SUP>®</SUP> tablet.
- Files in This Item
-
Go to Link
- Appears in
Collections - College of Pharmacy > School of Pharmacy > 1. Journal Articles
- College of Medicine > College of Medicine > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/32675)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.