Comparative Bioavailability of Two Tablet Formulations of Dipyridamole in Healthy Volunteers
| Author | Davood Beiki | en |
| Author | Mohsen Amini | en |
| Author | Reza Dowlatabadi | en |
| Author | Morteza Pirali | en |
| Issued Date | 2003-10-31 | en |
| Abstract | The bioavailability of two dipyridamol tablet formulations of (Dipyridamole from Tolidaru and Persantin from Boehringer) was compared in 14 healthy male volunteers who received a single dose of 25 mg of the test (T) and the reference (R) products in a randomized balanced 2- way crossover design. Plasma samples were obtained over a 16 h interval and dipyridamole concentrations determined by HPLC with ultraviolet detection. The maximum plasma concentration (Cmax), area under the plasma concentration time curve up to the last measurable concentration (AUC0-t), as well as infinity (AUC0-∞), and the absorption rate (Cmax/AUC0-∞) were analyzed statistically under the assumption of a multiplicative model. The time to maximum concentration (Tmax) was analyzed assuming an additive model. The parametric confidence intervals (90%) of the mean values of the pharmacokinetic characteristics for T/R ratio were in each case well within the bioequivalence acceptable range of 80-125%. The test formulation was found bioequivalent to the reference formulation by the Schuirmann’s two one-sided t tests and by Wilcoxon Mann Whitney two one-sided tests procedure. Therefore, the 2 formulations were considered to be equivalent. | en |
| DOI | https://doi.org/10.22037/ijpr.2010.58 | en |
| URI | https://brieflands.com/journals/ijpr/articles/127973 | en |
| Keyword | Bioequivalent | en |
| Keyword | Pharmacokinetic parameters | en |
| Keyword | Comparative bioavailability | en |
| Keyword | Dipyridamole | en |
| Publisher | Brieflands | en |
| Title | Comparative Bioavailability of Two Tablet Formulations of Dipyridamole in Healthy Volunteers | en |
| Type | Research Article | en |
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