Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00972595
First received: September 3, 2009
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: May 19, 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: ondansetron clinical trial formulation
Drug: ondansetron marketed formulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OE U.K. Tablet Then U.K. Tablet Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
U.K. Tablet Then OE U.K. Tablet U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally

Participant Flow for 2 periods

Period 1:   Period 1
    OE U.K. Tablet Then U.K. Tablet     U.K. Tablet Then OE U.K. Tablet  
STARTED     23     22  
COMPLETED     22     22  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Period 2
    OE U.K. Tablet Then U.K. Tablet     U.K. Tablet Then OE U.K. Tablet  
STARTED     22     22  
COMPLETED     22     22  
NOT COMPLETED     0     0  



  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  
Number of Participants  
[units: participants]
  45  
Age  
[units: Years]
Mean ( Full Range )
  34  
  ( 18 to 54 )  
Gender  
[units: participants]
 
Female     26  
Male     19  
Height  
[units: Centimeters]
Mean ( Full Range )
  170.8  
  ( 154.9 to 188.0 )  
Weight  
[units: Killograms]
Mean ( Full Range )
  72.0  
  ( 45.5 to 102.7 )  



  Outcome Measures
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1.  Primary:   Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron   [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose ]

2.  Primary:   Peak Plasma Concentration (Cmax) for 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00972595     History of Changes
Other Study ID Numbers: 0869-106, MK0869-106, 2009_657
Study First Received: September 3, 2009
Results First Received: May 19, 2010
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration