Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.

摘要: This study was conducted with the aim to determine pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation reference product (Caflam). Present single dose, randomized, two phase cross over design, in 12 healthy Pakistani volunteers planned accordance FDA guidelines. In this a simple, selective, sensitive reproducible HPLC procedure developed validated for estimation plasma. The process range - 0.05 µg.mL-1 used trial products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 14 hr after treating marketed brand. Plasma separation deproteination carried out acetonitrile; (20µL) injected using method. Various parameters (compartmental noncompartmental) estimated KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among products established by calculating 90% CI log non transformed data Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot AUClast way ANOVA Schirmann's Two one sided t- test. No significant difference found between non-log data. confidence interval values AUC0-∞ (0.997-1.024), (1.004-1.031), (0.997 -1.024), Cmaxcalc (0.994-1.007) Tmaxcalc (0.996-1.013) within acceptable limits 0.8-1.25. Results further verified one-sided t showed formulations. Both well tolerated.