Comparative Bioavailability of Two Tablet Formulations of Dipyridamole in Healthy Volunteers

Authors

  • D Beiki
  • M Amini
  • M Pirali
  • R Dowlatabadi
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.

Upgrade to premium to download articles

Sign up to access the full text

Already have an account?login

similar resources

comparative bioavailability of two tablet formulations of dipyridamole in healthy volunteers

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 ...

full text

Comparative Bioavailability Study of Two Ramipril Tablet Formulations in Indonesian Healthy Volunteers

A single-dosed, open-label, randomized two-way crossover design under fasting period with two weeks wash out period was evaluated in 24 subjects. For the analysis of pharmacokinetic properties, the blood samples were drawn taken up to 72 hours after dosing. Plasma concentration of ramipril and ramiprilat were determined using liquid chromatography – tandem mass spectrometry method with TurboIon...

full text

Comparative bioavailability of two cetirizine tablet formulations in Indonesian healthy volunteers.

AIM To compare the bioavailability of two cetirizine tablet (10 mg) formulations (ZyrtecA from UCB Pharma, Spain as a reference formulation and RyvelA from Novell Pharmaceutical Laboratories, Indonesia as a test formulation). MATERIAL AND METHODS The study was conducted according to an open, randomized, two-period crossover design with a 1-week washout period. Eighteen volunteers participated...

full text

Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers

The relative bioavailability of the test (generic) product 2 × 25 mg baclofen tablets, with respect to the reference product, Lioresal® 2 × 25 mg tablets (baclofen; Squibb) was determined in a single-blind, single dose, randomised, crossover study. The mean values for the variable Cmax were 737.6 ng/ml for the reference and 739.5 ng/ml for the test product. The mean values for the variable AUC ...

full text

Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers

The relative bioavailability of the test (generic) product 2 × 25 mg baclofen tablets, with respect to the reference product, Lioresal® 2 × 25 mg tablets (baclofen; Squibb) was determined in a single-blind, single dose, randomised, crossover study. The mean values for the variable Cmax were 737.6 ng/ml for the reference and 739.5 ng/ml for the test product. The mean values for the variable AUC ...

full text

My Resources

Save resource for easier access later

Save to my library Already added to my library

{@ msg_add @}


Journal title

volume Volume 2  issue Number 4

pages  213- 216

publication date 2010-11-20

By following a journal you will be notified via email when a new issue of this journal is published.

Hosted on Doprax cloud platform doprax.com

copyright © 2015-2023