About this Journal Submit a Manuscript Table of Contents
ISRN Pharmacology
Volume 2012 (2012), Article ID 375134, 6 pages
http://dx.doi.org/10.5402/2012/375134
Research Article

Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers

Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand

Received 26 June 2012; Accepted 16 August 2012

Academic Editors: G. M. Campo, T. B. Vree, K. Wada, and S.-N. Wu

Copyright © 2012 Noppamas Rojanasthien et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. D. B. Campbell, R. Lavielle, and C. Nathan, “The mode of action and clinical pharmacology of gliclazide: A review,” Diabetes Research and Clinical Practice, vol. 14, supplement 2, pp. S21–S36, 1991. View at Publisher · View at Google Scholar · View at Scopus
  2. K. J. Palmer and R. N. Brogden, “Gliclazide—an update of its pharmacological properties and therapeutic efficacy in non-insulin-dependent diabetes mellitus,” Drugs, vol. 46, no. 1, pp. 92–125, 1993. View at Scopus
  3. K. G. Alberti, “Gliclazide: review of metabolic and vascular action,” Diabète & Métabolisme, vol. 20, no. 3, part 2, pp. 341–348, 1994 (French).
  4. P. E. Jennings, “From hemobiology to vascular disease: a review of the potential of gliclazide to influence the pathogenesis of diabetic vascular disease,” Journal of Diabetes and its Complications, vol. 8, no. 4, pp. 226–230, 1994. View at Publisher · View at Google Scholar · View at Scopus
  5. G. Schernthaner, “Gliclazide modified release: a critical review of pharmacodynamic, metabolic, and vasoprotective effects,” Metabolism, vol. 52, no. 8, supplement 1, pp. 29–34, 2003. View at Publisher · View at Google Scholar · View at Scopus
  6. A. Harrower, “Gliclazide modified release: from once-daily administration to 24-hour blood glucose control,” Metabolism, vol. 49, no. 10, supplement 2, pp. 7–11, 2000. View at Scopus
  7. P. Drouin, “Diamicron®MR once daily is effective and well tolerated in type 2 diabetes: a double-blind, randomized, multinational study,” Journal of Diabetes and its Complications, vol. 14, no. 4, pp. 185–191, 2000. View at Publisher · View at Google Scholar · View at Scopus
  8. J. K. McGavin, C. M. Perry, and K. L. Goa, “Gliclazide modified release,” Drugs, vol. 62, no. 9, pp. 1357–1364, 2002. View at Scopus
  9. P. Delrat, M. Paraire, and R. Jochemsen, “Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers,” Biopharmaceutics and Drug Disposition, vol. 23, no. 4, pp. 151–157, 2002. View at Publisher · View at Google Scholar · View at Scopus
  10. F. Ishibashi and S. Takashina, “The effect of timing on gliclazide absorption and action,” Hiroshima Journal of Medical Sciences, vol. 39, no. 1, pp. 7–9, 1990. View at Scopus
  11. J. F. Yang, G. L. Wei, R. Lu, C. X. Liu, B. Z. Zheng, and P. Feng, “Bioavailability of gliclazide sustained release tablet in healthy volunteers,” Asian Journal of Pharmacodynamics and Pharmacokinetics, vol. 6, no. 2, pp. 153–160, 2006.
  12. Center for Drug Evaluation and Research (CDER), Guidance for Industry, Food-Effect Bioavailability and Fed Bioequivalence Studies, US FDA, 2002.
  13. Center for Drug Evaluation and Research (CDER), Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, US FDA, 2003.
  14. H. Noguchi, N. Tomita, S. Naruto, and S. Nakano, “Determination of gliclazide in serum by high-performance liquid chromatography using solid-phase extraction,” Journal of Chromatography, vol. 583, no. 2, pp. 266–269, 1992. View at Publisher · View at Google Scholar · View at Scopus