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Impact of food administration on lopinavir-ritonavir bioequivalence studies.
- Source :
-
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2012 Aug 15; Vol. 46 (5), pp. 516-21. Date of Electronic Publication: 2012 Apr 13. - Publication Year :
- 2012
-
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.<br /> (Copyright © 2012 Elsevier B.V. All rights reserved.)
- Subjects :
- Administration, Oral
Adolescent
Adult
Area Under Curve
Cross-Over Studies
Drug Combinations
Female
HIV Protease Inhibitors administration & dosage
HIV Protease Inhibitors blood
Half-Life
Humans
Lopinavir administration & dosage
Lopinavir blood
Male
Postprandial Period
Ritonavir administration & dosage
Ritonavir blood
Sex Factors
Therapeutic Equivalency
Uruguay
Young Adult
Food-Drug Interactions
HIV Protease Inhibitors pharmacokinetics
Lopinavir pharmacokinetics
Ritonavir pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0720
- Volume :
- 46
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
- Publication Type :
- Academic Journal
- Accession number :
- 22522225
- Full Text :
- https://doi.org/10.1016/j.ejps.2012.04.004