A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00971633
First received: September 3, 2009
Last updated: July 30, 2010
Last verified: July 2010
Results First Received: July 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chemotherapy-Induced Nausea and Vomiting
Interventions: Drug: Comparator: Treatment A (Zofran, ondansetron)
Drug: Comparator: Treatment B (Zofran, ondansetron)
Drug: Comparator: Treatment C (Zofran, ondansetron)

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants All randomized participants

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ( Full Range )
  31.7  
  ( 25 to 41 )  
Gender  
[units: participants]
 
Female     5  
Male     7  
Weight  
[units: kilograms]
Mean ( Full Range )
  78.5  
  ( 61.1 to 101.0 )  
Height  
[units: centimeters]
Mean ( Full Range )
  171.1  
  ( 155 to 183 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron   [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of Ondansetron   [ Time Frame: 24 hours post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information