Impact of food administration on lopinavir-ritonavir bioequivalence studies.
Eur J Pharm Sci
; 46(5): 516-21, 2012 Aug 15.
Article
em En
| MEDLINE
| ID: mdl-22522225
ABSTRACT
A bioequivalence study in 16 Caucasian healthy volunteers (eight male, eight female), comparing plasma drug concentrations after a single oral dose of lopinavir and ritonavir (400 and 100mg, respectively), was carried out following a two-period, two-sequence, two-treatment, randomized crossover design. Formulations were given 15 min after a moderate-fat breakfast in order to diminish both the intrinsic highly-variable performance and the sex differences observed in bioequivalence trials under fasting conditions. Ninety percent confidence intervals for the Test/Reference (T/R) ratio of geometric means for area under concentration-time curve (AUC) and maximum concentration (C(MAX)), either for lopinavir or ritonavir, were within the range of 0.80-1.25. Coprandial administration of formulations not only reduced the number of subjects required for bioequivalence assessment, reducing both ethical and economic cost of the trial, but also the sex differences in the T/R ratio of means.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Inibidores da Protease de HIV
/
Interações Alimento-Droga
/
Ritonavir
/
Lopinavir
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
America do sul
/
Uruguay
Idioma:
En
Revista:
Eur J Pharm Sci
Assunto da revista:
FARMACIA
/
FARMACOLOGIA
/
QUIMICA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Uruguai