Bioequivalence test applied to a new lamivudine/zidovudine combined formulation tablet
A double-center, open-label, two-way crossover study was conducted in 24 healthy volunteers to assess the bioequivalence of a combined lamivudine/zidovudine tablet related to a reference and test drug products. The volunteers were randomly assigned to receive one lamivudine/zidovudine combination ta...
Guardado en:
| Autores principales: | , , , , , |
|---|---|
| Formato: | Articulo |
| Lenguaje: | Inglés |
| Publicado: |
2009
|
| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/7779 http://www.latamjpharm.org/trabajos/28/3/LAJOP_28_3_1_16_V0B1X2XE46.pdf |
| Aporte de: |
| Sumario: | A double-center, open-label, two-way crossover study was conducted in 24 healthy volunteers to assess the bioequivalence of a combined lamivudine/zidovudine tablet related to a reference and test drug products. The volunteers were randomly assigned to receive one lamivudine/zidovudine combination tablet of reference or test product with 7-days washout period between. Blood samples were collected up to 36 h post dose. Pharmacokinetic parameters were estimated. Drug products were bioequivalent if 90% confidence intervals for the ratio of least squares (CI 90%) means are under plasma concentration-time curve (AUC<sub>0-τ</sub> ) and absorption rate (C<sub>max</sub>) fell within 80 to 125% for log-transformed parameters. Test and reference products present data of AUC<sub>0-τ</sub> , C<sub>max</sub> referents to lamivudine and data of ASC∞ referents to zidovudine, in agreement of these limits. The result of C<sub>max</sub> (CI 90%) to zidovudine was: 116% (90- 141%), it has confirm that the zidovudine has high individual variability of absorption. |
|---|