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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835549
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
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: Cefdinir for oral suspension 250 mg/5mL
Drug: OMNICEF® for oral suspension 250 mg/5mL

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

Participant Flow for 3 periods

Period 1:   First Intervention
    Cefdinir (Test) First   Omnicef® (Reference) First
STARTED   16   16 
COMPLETED   16   16 
NOT COMPLETED   0   0 

Period 2:   Washout of 7 Days
    Cefdinir (Test) First   Omnicef® (Reference) First
STARTED   16   16 
COMPLETED   14   16 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 

Period 3:   Second Intervention
    Cefdinir (Test) First   Omnicef® (Reference) First
STARTED   14   16 
COMPLETED   14   16 
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.
No text entered.

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

Baseline Measures
   Cefdinir (Test) First   Omnicef® (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   16   32 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   5   7   12 
Male   11   9   20 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   11   10   21 
White   5   6   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   6   9 
Not Hispanic or Latino   13   10   23 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   16   16   32 


  Outcome Measures
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1.  Primary:   Cmax (Maximum Observed Concentration)   [ Time Frame: Blood samples collected over a 14 hour period. ]

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 14 hour period. ]

3.  Primary:   AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 14 hour period. ]


  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: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com



ClinicalTrials.gov Identifier: NCT00835549     History of Changes
Other Study ID Numbers: B056502
Study First Received: January 30, 2009
Results First Received: June 18, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board