[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974

 
Abstracts

DOI: https://doi.org/10.14456/mujps.2015.15Pharm Sci Asia 2015; 42(3), 118-125
 

Bioequivalence study of Ribavirin 400 mg tablets in healthy Thai male volunteers under fed conditions

J. 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.)





Vol.42
No.4
October - December 2015

See other volume

 


Vol.42
No.3
July - September 2015

See other volume

 


Vol.42
No.2
April - June 2015

See other volume

 


Vol.42
No.1
January - March 2015

See other volume

 
 
 

Home
Aims and Scope
Editorial Board
Publication Ethics
Instruction to Authors
Announcement
All Volumes & Issues
Submit Online
Contact us
   
Search
   
Faculty of Pharmacy Mahidol University
Mahidol University
Member's menu

You're now loging on with following account:
Guest (unknown)

Please Sign in or Register



    Copyright © 2017
    Faculty of Pharmacy, Mahidol University, THAILAND