Bioequivalence Evaluation of Digoxin Tablets C.S.D 0.125 mg Under Fed Conditions in Healthy Adult Subjects
Dr. M. Narender, Dr. K. Ramulu, Clinical
DOI: https://doi.org/10.63712/bpsrj-v2i2p002
ABSTRACT:
A randomized, double-blind, twotreatment, two-sequence, two-period crossover study was conducted to evaluate the bioequivalence of Digoxin Tablets C.S.D 0.125 mg manufactured by Chormo labs Ltd compared with the reference product PrToloxin® 0.125 mg. The study was performed in healthy adult volunteers under fed conditions. A single oral dose of two tablets (0.25 mg total dose) was administered in each study period with an appropriate washout interval between periods. Plasma concentrations of digoxin were determined using a validated LC–MS/MS method, and pharmacokinetic parameters were calculated using a non-compartmental approach. Statistical analysis was performed on logarithmically transformed pharmacokinetic parameters to assess bioequivalence. The 90% confidence interval for AUC0-72h was within the predefined acceptance range, whereas the interval for Cmax did not fully meet the regulatory bioequivalence criteria.