Text Size

Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835354
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
History of Changes
Results First Received: June 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: Cefprozil for oral suspension 250 mg/5 mL
Drug: CEFZIL® for Oral Suspension 250 mg/5mL

  Participant Flow
  Hide Participant Flow

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
Cefprozil (Test) First 250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
Cefzil® (Reference) First 250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Cefprozil (Test) First     Cefzil® (Reference) First  
STARTED     13     13  
COMPLETED     13     12  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  

Period 2:   Washout of 7 Days
    Cefprozil (Test) First     Cefzil® (Reference) First  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Cefprozil (Test) First     Cefzil® (Reference) First  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Cefprozil (Test) First 250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
Cefzil® (Reference) First 250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Cefprozil (Test) First     Cefzil® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  13     13     26  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     8     5     13  
Male     5     8     13  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black     2     0     2  
White     11     13     24  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     0     1     1  
Not Hispanic or Latino     13     12     25  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     13     13     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax (Maximum Observed Concentration)   [ Time Frame: Blood samples collected over a 12 hour period. ]
  Show Outcome Measure 1

2.  Primary:   AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 12 hour period. ]
  Show Outcome Measure 2

3.  Primary:   AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 12 hour period. ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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: NCT00835354     History of Changes
Other Study ID Numbers: B036559
Study First Received: January 30, 2009
Results First Received: June 18, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board