PHARMACOKINETICS AND BIOEQUIVALENCE STUDIES OF WARFARIN SODIUM 5 MILLIGRAMS TABLET IN HEALTY THAI SUBJECTS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 3
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.Â
Authors and Affiliations
Chuleegone Sornsuvit, Narawadee Niamhun, Nutthida Luengpiansamut, Siriluk Sangsrijan, Wirat Niwatananum, Sayam Kaewvichit, Darunee Hongwiset, Nontakan Nuntachit, Songwut Yotsawimonwat
Keywords
Related Articles
- EP ID EP578961
- DOI -
- Views 96
- Downloads 0
IN VITRO CYTOTOXICITY EFFECT ON MCF-7 CELL LINE OF CO-ENCAPSULATED ARTESUNATE AND CURCUMIN LIPOSOME
Objective: Cancer drug delivery has focused using novel carrier system due to their high drug loading and release controlled property and minimum side effect. Artesunate (ART) and curcumin (CUR) are proved natural herbal...
DETERMINATION OF 4, 4′-BIS (BROMOMETHYL) BIPHENYL GENOTOXIC IMPURITY IN VALSARTAN DRUG SUBSTANCES BY HPLC
Objective: The objective of the present study was to develop and validate a specific and sensitive analytical method, which separate the genotoxic impurity 4, 4’-bis (bromomethyl) biphenyl from valsartan antihypertensi...
PRODUCTION OF ANTIMICROBIAL AND ANTICANCER FOM FEATHER-KERATINOLYTIC NOCARDIOPSIS SP. 28ROR AS A NOVEL STRAIN USING FEATHER MEAL MEDIUM
Objective: Production of bioactive secondary metabolites from a feather-degrading actinobacterial species using feather meal medium. Methods: Protease producer actinobacterial isolates (22) recovered from farm soil, poul...
ELECTRONIC ABSORPTION SPECTRA OF SOME PHOTOSENSITIZERS BEARING CARBOXYLIC ACID GROUPS: INSIGHTS FROM THEORY
Objective: The main objective of this research work was to give insight from theory in interpreting electronic absorption spectra of tetrapyrrolic macrocycles bearing carboxylic acid groups: protoporphyrin IX, pheophorbi...
STANDARDISATION AND HPTLC METHOD DEVELOPMENT OF MARKETED AYURVEDIC FORMULATION – BALARISHTA
Objective: The present study aims to standardize four marketed brands of Balarishta, an Ayurvedic formulation viz. Baidyanath-Balarishta (BB), Dabur-Balarishta (DB), Zandu-Balarishta (ZB) and Nagarjuna-Balarishta (NB) wi...