Bioequivalence studies of celiprolol in healthy human volunteers.
Thus bioequivalence between the two products was established by undertaking this study. From table 1 it can be seen that the standard deviation at the various sampling points is high indicating varying absorption rates in individual volunteers, but this was observed in case of both the products. Also, since the study design was complete crossover, this high standard deviation was not due to any study design variable. As celiprolol shows non-linear1 dose related absorption kinetics this high value of standard deviation may be due to the intersubject variation during the absorption process. However all the pharmacokinetic parameters showed a comparable profile when statistically evaluated for any significant difference between the two products.
Iyer
E K
EK
Bombay College of Pharmacy, Kalina, Santacruz E.
Tipnis
H P
HP
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000328:Adult; D017272:Celiprolol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D013810:Therapeutic Equivalency
D000319:Adrenergic beta-Antagonists; D017272:Celiprolol