Comparative bioavailability of three different preparations of rifampicin.
J Clin Pharm Ther
; 24(3): 219-25, 1999 Jun.
Article
en En
| MEDLINE
| ID: mdl-10438182
ABSTRACT
OBJECTIVE:
To study the relative bioavailabilities of two generic rifampicin preparations with Rimactane.METHOD:
Each of nineteen healthy volunteers received a single oral dose of 600 mg of rifampicin in an open cross-over randomised three-way single-dose design with a washout period of 7 days between each doses. Plasma concentrations of rifampicin were determined by HPLC. In vitro dissolution profiles of the same drugs were determined and compared with human bioavailability study results.RESULTS:
No statistically significant difference was found in main bioavailability parameters between Rimactane and generic preparations studied. Both generic preparations also fulfilled the bioequivalence criteria based on the 90% confidence intervals. There was a good correlation between in vivo and in vitroresults:
faster dissolution time corresponded to the lower Tmax value; lower percentage of released compound to the lower AUC value. Significant intersubject variations were found in main bioavailability parameters; significant negative correlation was found between average AUC values and body weight of the volunteer.CONCLUSION:
All three products were bioequivalent. Our results also suggest the suitability of one-compartmental model with lag time, first order input and first order output to describe the kinetics of rifampicin.
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Base de datos:
MEDLINE
Asunto principal:
Rifampin
/
Antibióticos Antituberculosos
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Revista:
J Clin Pharm Ther
Asunto de la revista:
FARMACIA
/
TERAPEUTICA
Año:
1999
Tipo del documento:
Article