600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840840
First received: February 6, 2009
Last updated: July 8, 2009
Last verified: July 2009
Results First Received: May 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
Drug: Augmentin ES-600™

  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
Test First Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
Reference First AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period

Participant Flow for 2 periods

Period 1:   Period 1
    Test First     Reference First  
STARTED     24     24  
COMPLETED     24     24  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Test First     Reference First  
STARTED     23 [1]   24  
COMPLETED     23     24  
NOT COMPLETED     0     0  
[1] One subject was withdrawn due to AE after Period 1



  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
Test First Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
Reference First AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
Total Total of all reporting groups

Baseline Measures
    Test First     Reference First     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     24     48  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     12     12     24  
Male     12     12     24  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     20     18     38  
Black     3     4     7  
Asian     1     2     3  
Region of Enrollment  
[units: participants]
     
Canada     24     24     48  



  Outcome Measures
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1.  Primary:   Bioequivalence Based on Cmax for Amoxicillin   [ Time Frame: Blood samples collected over 14 hour period ]

2.  Primary:   Bioequivalence Based on AUC0-inf for Amoxicillin   [ Time Frame: Blood samples collected over 14 hour period ]

3.  Primary:   Bioequivalence Based on AUC0-t for Amoxicillin   [ Time Frame: Blood samples collected over 14 hour period ]

4.  Primary:   Bioequivalence Based on Cmax for Clavulanic Acid   [ Time Frame: Blood samples collected over 14 hour period ]

5.  Primary:   Bioequivalence Based on AUC0-inf for Clavulanic Acid   [ Time Frame: Blood samples collected over 14 hour period ]

6.  Primary:   Bioequivalence Based on AUC0-t for Clavulanic Acid   [ Time Frame: Blood samples collected over 14 hour period ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


ClinicalTrials.gov Identifier: NCT00840840     History of Changes
Other Study ID Numbers: 02-544
Study First Received: February 6, 2009
Results First Received: May 18, 2009
Last Updated: July 8, 2009
Health Authority: Canada: Ethics Review Committee