The current requirement of the Mexican Authorities to demonstrate the interchangeability of ranitidine formulations is to establish that the dissolution profile of the drug shows similarity. In order to establish if this requirement is adequate, the bioavailability of two formulations that did not m
Relative bioavailability of two oral formulations of navelbine in cancer patients
โ Scribed by X. J. Zhou; X. R. Zhou-Pan; R. Favre; R. Rahmani
- Publisher
- John Wiley and Sons
- Year
- 1994
- Tongue
- English
- Weight
- 401 KB
- Volume
- 15
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
โฆ Synopsis
A study was carried out in 14 cancer patients to assess the relative bioavailability of two oral formulations of navelbine. A single 130 mg oral dose of the drug was given according to a randomized two-way crossover design as two capsules: one contained the drug in powder (formulation A, reference); another contained the drug in solution (formulation B). A 7 d washout period separated each dose. Navelbine was rapidly absorbed after administration of either formulation and exhibited a biphasic concentration decay pattern. The peak plasma level was reached within 2 h of administration in most patients. Formulation B resulted in better navelbine absorption with respect to peak plasma concentration ( Cma) and area under the plasma concentration-time curves (AUC) than did formulation A as ascertained by analysis of variance (ANOVA). The relative bioavailabilities (solution versus powder) were, respectively, 286.0% and 268 -0010 as estimated from experimental (0-72 h) and extrapolated (0-00) AUC.
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