bioequivalence study on glafenine tablets in normal volunteers

ABSTRACT

The in vivo availability study has been performed on reference and test products of glafenine 200 mg tablets. The study was based on urinary excretion of glafenic acid in nine healthy volunteers. The given dose [400 mg] was administered according to a cross over design with 10 days as a washout interval. Tmax, Cmax and AUC of glafenic acid in urine demonstrated the possible bioequivalence of preparation under evaluation. The present work proposed the utility of use of optical density index [instead of glafenic acid concentration] for computation of the pharmacokinetic parameters