K. Bauerova et al., Bioavailability and pharmacokinetic studies in the development of an oral formulation of stobadine dipalmitate, METH FIND E, 21(7), 1999, pp. 499-503
Citations number
27
Categorie Soggetti
Pharmacology & Toxicology
Journal title
METHODS AND FINDINGS IN EXPERIMENTAL AND CLINICAL PHARMACOLOGY
The pyridoindole stobadine is a novel drug with antioxidant and cardioprote
ctive properties. The objective of this study was to compare the bioavailab
ility and the main pharmacokinetic parameters of two different stobadine do
sage forms, STBtest and STBref ; after single oral dosing in the form ofgel
atine capsules to 6 dogs. The dose ranged from 2.9 to 4.7 mg/kg and a rando
mized two-period crossover design was applied To quantify the drug in plasm
a, a GC/MS method was developed with a quantification limit of I ng/inl. Th
e time profiles of stobadine plasma concentrations were fitted by pharmacok
inetic models. The extent of relative bioavailability ranged between 0.71 t
md 1.56. practically no difference,was found between the bioavailability ra
te of the two capsules, expressed as C-max/AUC, with values ranging from 0.
0022-0.0047 min(-1) for STBtest and 0.0022-0.0045 min(-1) for STBref: In co
nclusion, the technological difference of the capsules investigated did not
yield deviations in either their extent or rare of absorption. Therefore t
he two stobudine formulations were concluded to be bioequivalent. (C) 1999
Prous Science. All rights reserved.