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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00971633
First received: September 3, 2009
Last updated: September 13, 2016
Last verified: September 2016
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
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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.
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Reporting Groups
  Description
All Participants All randomized participants

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[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
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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
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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
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