Paper Information

Journal:   IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)   Fall 2003 , Volume 2 , Number 4; Page(s) 213 To 216.
 
Paper: 

COMPARATIVE BIOAVAILABILITY OF TWO TABLET FORMULATIONS OF DIPYRIDAMOLE IN HEALTHY VOLUNTEERS

 
 
Author(s):  BEYKI D.*, AMINI MOHSEN, DOULATABADI R., PIRALI M.
 
* RESEARCH INSTITUTE FOR NUCLEAR MEDICINE, TEHRAN UNIVERSITY OF MEDICAL SCIENCES, SHARIATI HOSPITAL, TEHRAN, IRAN
 
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.

 
Keyword(s): DIPYRIDAMOLE, COMPARATIVE BIOAVAILABILITY, PHARMACOKINETIC PARAMETERS, BIOEQUIVALENT
 
References: 
  • ندارد
 
  pdf-File tarjomyar Yearly Visit 82
 
Latest on Blog
Enter SID Blog