Bioequivalence of two oral immediate release formulations of pindolol in healthy volunteers assessed by ratio analysis.
The objective of this study was to test bioequivalence and therapeutic equivalence of two oral formulations of pindolol (ViskenR = Vs = Ref.; Nonspi 5R = Np = Test). Twenty one healthy volunteers (11 females; 10 males; aged 18-55 years) participated in the single-dose (10 mg), single-blind, randomised crossover study. Blood samples were taken up to 24 hs after intake and pindolol in serum was determined using HPLC. Key criteria for ratio analysis to assess bioequivalence were log-transformed AUC (0, last) and Cmax. Blood pressure and heart rate vs. time data were subjected to ANOVA according to Friedman. Vital signs did not show significant differences. Ratios of log-transformed data and 90%-confidence intervals were within the predefined limits of 0.8 to 1.25 or 0.7 and 1.43, respectively. We conclude that both formulations of pindolol are equivalent with regard to extent and rate of absorption as well as pharmacodynamic effect.
Koch
H J
HJ
Department of Gerontopsychiatry, University Hospital Regensburg, Germany. horst.koch@bkr-regensburg.de
Raschka
C
C
Hannak
D
D
D000319:Adrenergic beta-Antagonists / Q000493:pharmacokinetics; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010869:Pindolol / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D000319:Adrenergic beta-Antagonists; D002214:Capsules; D010869:Pindolol