| DOI: https://doi.org/10.14456/mujps.2015.15 | Pharm Sci Asia 2015; 42(3), 118-125 |
Bioequivalence study of Ribavirin 400 mg tablets in healthy Thai male volunteers under fed conditionsJ. Vattanarongkup1, E. Yoosakul1, C. Manamuti1, P. Teerawonganan1, C. Seeduang1, P. Ratnatilaka Na Bhuket1, A. Rojanawiwat2, B. Karachot1, B. Chuasuwan1, I. Techatanawat1*
1 Research and Development Institute, The Government Pharmaceutical Organization, Bangkok, Thailand
2 Clinical Research Center, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand
Ribavirin is a nucleoside analogue that exerts an antiviral activity. It mostly uses as a combination with interferon alfa-2b for hepatitis C treatment. Development of a generic product of ribavirin would be benefit for hepatitis C patient in Thailand. The purpose of this study is to investigate the bioequivalence of the generic formulation, Ribavirin GPO 400 mg tablets compared to an originator, Copegus? 400 mg tablets. A randomized, single dose, two-way crossover, open-label bioequivalence study in healthy Thai male volunteers under fed conditions with 6 weeks washout period was conducted. The plasma samples were collected and the ribavirin concentration was analyzed using validated liquid chromatography tandem mass spectrometry method. The pharmacokinetic parameters including of area under the plasma concentration time curve from time 0 hour to 72 hours (AUC0-72), the peak plasma concentration (Cmax) and time to achieve the Cmax (Tmax) were determined by using non-compartmental model. The 90% parametric confidence intervals (90% CI) values for the ratio of AUC0-72 and Cmax of test/reference product were 101.3 (95.73-107.17) and 99.6 (92.50-107.32), respectively. These values were within the acceptable range (80.00 – 125.00%). No adverse effect was observed during the study. The results of this study indicated that both formulation of ribavirin, Ribavirin GPO 400 mg tablets and Copegus? 400 mg tablet were bioequivalent in term of rate and extent of drug absorption.
Keyword:
Ribavirin, Pharmacokinetics, Bioequivalence, Liquid chromatography tandem mass spectrometry
Download full paper (PDF File size: 468.37 KB.)
|
