A BIOEQUIVALENCE STUDY OF 2 BRANDS OF SUMATRIPTAN TABLETS

In this double-masked, randomized, crossover, bioequivalence study, tw o 100-mg tablet preparations of sumatriptan (Suminat(R) and Imigran(R) ) were compared in 12 healthy male subjects (mean +/- SD age, 25 +/- 6 years). Pharmacokinetic variables-mean maximum plasma concentration, time to reach mean maximum plasma concentration, and the mean area und er the plasma concentration-time curve-were not statistically signific antly different for the two treatment groups. Vital variables, such as blood pressure and heart rate, also did not show any significant betw een-group differences. Statistical analysis revealed no difference in the two formulations. It can be concluded that the two tablet preparat ions of sumatriptan are likely to be bioequivalent.