Relative bioavailability of two oral formulations of navelbine in cancer patients

Biopharm Drug Dispos. 1994 Oct;15(7):577-86. doi: 10.1002/bdd.2510150705.


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 (Cmax) 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 268.0% as estimated from experimental (0-72 h) and extrapolated (0-infinity) AUC.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorption
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / blood
  • Antineoplastic Agents / pharmacokinetics*
  • Biological Availability
  • Capsules
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Drug Delivery Systems
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / metabolism*
  • Solutions
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives*
  • Vinblastine / blood
  • Vinblastine / pharmacokinetics
  • Vinorelbine


  • Antineoplastic Agents
  • Capsules
  • Solutions
  • Vinblastine
  • Vinorelbine