PHARMACOKINETICS AND BIOEQUIVALENCE STUDIES OF WARFARIN SODIUM 5 MILLIGRAMS TABLET IN HEALTY THAI SUBJECTS

Authors

  • Chuleegone Sornsuvit Chiang Mai University
  • Narawadee Niamhun Chiang Mai University
  • Nutthida Luengpiansamut Chiang Mai University
  • Siriluk Sangsrijan Chiang Mai University
  • Wirat Niwatananum Chiang Mai University
  • Sayam Kaewvichit Chiang Mai University
  • Darunee Hongwiset Chiang Mai University
  • Nontakan Nuntachit Chiang Mai University
  • Songwut Yotsawimonwat Chiang Mai University

Keywords:

Pharmacokinetic, Bioequivalence, Warfarin, HPLC, Validation, Human plasma

Abstract

Objective:  The present study aimed to evaluate the bioequivalence between the generic warfarin sodium tablet and a reference product when gave as equal labeled doses in healthy Thai subjects under fasting condition.

Methods:  A randomized, open-label, single dose, two treatments, two periods, two sequences, crossover design between 5 mg of warfarin administration under fasting condition was conducted in 22 male and female healthy Thai subjects. Each subject was assigned randomly to receive a single oral dose of the test formulation or the reference formulation of 5 mg warfarin tablets. Study periods were separated by a 14-day washout period. Blood samples were collected at 0.0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 4.0, 8.0, 12.0, 24.0, 36.0, 48.0 and 72.0 h after drug administration. A simple, sensitive and specific HPLC method was used for quantification of warfarin in plasma. Pharmacokinetic parameters were analyzed including Cmax, Tmax, t1/2 and AUC0-72h.

Results:  Twenty subjects, selected randomly from healthy adult Thai subjects were enrolled, age of 22.5 + 3.1 years, weight, 59 + 6 kg. Twenty-one subjects completed both periods of the study. The mean Cmax values were 759.63 and 778.20 ng/ml and the mean AUC0-72h were 20010.89 and 20418.55 ng. h./ml for test and reference formulations, respectively. The mean ratios for log-transformed data were 0.9955 and 0.9971 for Cmax, and AUC0-72h, respectively. The 90% confidence intervals of the ratios of Cmax and AUC0-72h between test and reference tablets were 88.23% – 105.70% and 94.40% – 99.61%.

Conclusion:  It can be concluded that test and reference warfarin 5 mg products were bioequivalent in terms of rate and extent of absorption.

 

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Published

01-03-2015

How to Cite

Sornsuvit, C., N. Niamhun, N. Luengpiansamut, S. Sangsrijan, W. Niwatananum, S. Kaewvichit, D. Hongwiset, N. Nuntachit, and S. Yotsawimonwat. “PHARMACOKINETICS AND BIOEQUIVALENCE STUDIES OF WARFARIN SODIUM 5 MILLIGRAMS TABLET IN HEALTY THAI SUBJECTS”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 3, Mar. 2015, pp. 219-22, https://mail.innovareacademics.in/journals/index.php/ijpps/article/view/4532.

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Original Article(s)