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

Participant Flow for 3 periods

Period 1:   Period 1
    OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet     U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet     U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet     OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet     U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet     U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

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

Period 3:   Period 3
    OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet     U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet     U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet     OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet     U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet     U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     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.
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
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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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  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: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00971633     History of Changes
Other Study ID Numbers: 2009_656, MK0869-095
Study First Received: September 3, 2009
Results First Received: July 30, 2010
Last Updated: July 30, 2010
Health Authority: United States: Food and Drug Administration