A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0-144 hours post dose ] [ Designated as safety issue: No ]
  
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  
• Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  Determined Using the Linear Trapezoidal Rule
  
  
• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  AUCinf = AUClast + (Clast/lamda z)
  
  
• Percentage of AUCinf Based on Extrapolation (AUCextrap) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  
• Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  Estimated via linear regression of the time versus log concentration
  
  
• Observed Terminal Elimination Half-Life (t1/2) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  t1/2 = [ln(2)/λ z]
  
  
• Time of Last Measurable Concentration (Tlast) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  
• Last Quantifiable Drug Concentration (Clast) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  
• Mean Residence Time (MRTinf) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  MRT = (AUMCinf)/(AUCinf)
  
  

Drug: Vinorelbine Tartrate
Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.
Other Names:
• Exelbine (proposed)
• ANX-530

ANX-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier dispersed in an aqueous solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California, developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product. In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model, suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE in these settings.