Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.
Article
Dans Anglais
| IMSEAR
| ID: sea-87212
ABSTRACT
OBJECTIVE:
To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand.METHODS:
A two-way randomised cross-over bioavailability study was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of clonazepam by high performance liquid chromatography (HPLC) method.RESULTS:
The mean Cmax, Tmax t1/2 beta and AUC (0-48) for Epitril were 16.31 +/- 3.07 ng/mL, 1.63 +/- 0.48 h, 46.97 +/- 12.26 h and 207.70 +/- 57.07 ng/ml.h; for reference brand were 19.75 +/- 5.95 ng/mL, 1.42 +/- 0.29 h, 46.88 +/- 11.29 h and 215.70 +/- 50.89 ng/ml.h respectively. These were comparable and the differences were not statistically significant.CONCLUSION:
Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
Texte intégral:
Disponible
Indice:
IMSEAR (Asie du Sud-Est)
Sujet Principal:
Valeurs de référence
/
Comprimés
/
Humains
/
Mâle
/
Biodisponibilité
/
Chimie pharmaceutique
/
Administration par voie orale
/
Analyse de variance
/
Chromatographie en phase liquide à haute performance
/
Sensibilité et spécificité
Type d'étude:
Essai clinique contrôlé
/
Etude diagnostique
langue:
Anglais
Année:
2000
Type:
Article
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