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Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg)
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2009, v.22 no.1, pp.101-108
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(2009). Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg). Analytical Science and Technology, 22(1), 101-108.
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Abstract
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.
- keywords
- pioglitazone, bioequivalence, LC-MS/MS, analytical validation
Reference
1
1. J. Waugh, G. M. Keating, G. L. Plosker, S. Easthope and D. M. Robinson, Drugs, 66, 85-109(2006).
2
2. Takeda Pharmaceutical Company Limited, Actos® (pioglitazone hydrochloride) Full Prescribing Information, Osaka, Japan, 2004, http://www.actos.com/pi.pdf.
3
3. J. M. Lehmann, L. B. Moore, T. A. Smith-Oliver, W. O. Wilkison, T. M. Willson and S. A. Kliewer, J. Biol. Chem., 270, 12953-12956(1995).
4
4. J. Sakamoto, H. Kimura, S. Moriyama, H. Odaka, Y. Momose, Y. Sugiyama and H. Sawada, Biochem. Biophys. Res. Commun., 278, 704-711 (2000).
5
5. J. Chilcott, MSc, P. Tappenden, M. L. Jones, M. A. DPhU and J. P. Wight, Clin. Therapeut., 23, 1792 (2001).
6
6. P. Sripalakit, P. Neamhom and A. Saraphanchotiwitthaya, J. Chromatogr. B, 843, 164-169(2006).
7
7. S. Wittayalertpanya, S. Chompootaweep and N. P. Thaworn, J. Med. Assoc. Thailand, 89, 2116-2122(2006).
8
8. 식품의약품안전청 고시 제 2007-65호, 생물학적동등 성시험기준 (2007. 09. 20).
9
9. Y. J. Xue, K. C. Turner, J. B. Meeker, J. Pursley, M. Arnold and S. Unger, J. Chromatogr. B, 795, 215- 226(2003).
10
10. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH-Q2A, Geneva, 1995.
11
11. FDA Guidelines, Bioequivalence Food and Drug Administration, Division of Bioequivalence, Office of Generic Drugs, Rockville, MD USA, 1992.
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