Evaluation on the bioequivalence of two domestic ribavirin tablets in Chinese healthy volunteers
Zhiwen Jiang
Abstract
Zhiwen Jiang
Abstract
Aim To investigate the bioequivalence of two domestic ribavirin tablets in Chinese healthy volunteers.Method Twenty volunteers were randomly divided into two groups(test and reference),with double cross over design.The concentration of ribavirin in serum was determined by HPLC and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results The pharmacokinetic parameters of two domestic ribavirin tablets were as follows:Cmax0.346±0.174 and 0.365±0.125 mg·L-1,Tmax1.475±0.436 and 1.588±0.731 h,AUC0-24 h 2.649±0.762 and 2.560±0.743 mg·h-1·L-1.The relative bioavailibility of ribavirin tablets was 111.99%±47.75%.Conclusion The statistical analysis showed that the test and reference preparation were bioequivalent.
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Aim To investigate the bioequivalence of two domestic ribavirin tablets in Chinese healthy volunteers.Method Twenty volunteers were randomly divided into two groups(test and reference),with double cross over design.The concentration of ribavirin in serum was determined by HPLC and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results The pharmacokinetic parameters of two domestic ribavirin tablets were as follows:Cmax0.346±0.174 and 0.365±0.125 mg·L-1,Tmax1.475±0.436 and 1.588±0.731 h,AUC0-24 h 2.649±0.762 and 2.560±0.743 mg·h-1·L-1.The relative bioavailibility of ribavirin tablets was 111.99%±47.75%.Conclusion The statistical analysis showed that the test and reference preparation were bioequivalent.
Key concepts: Bioequivalence, Ribavirin, Pharmacokinetics, Medicine, Pharmacology, Virology, Hepatitis C virus, Virus