A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00830206
First received: January 26, 2009
Last updated: September 1, 2009
Last verified: September 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: Other: Azithromycin
Drug: Zithromax®

  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
Azithromycin (Test) First Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
Zithromax® (Reference) First Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period

Participant Flow for 3 periods

Period 1:   First Intervention
    Azithromycin (Test) First     Zithromax® (Reference) First  
STARTED     40     40  
COMPLETED     40     40  
NOT COMPLETED     0     0  

Period 2:   Washout: 21 Days
    Azithromycin (Test) First     Zithromax® (Reference) First  
STARTED     40     40  
COMPLETED     39     39  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  

Period 3:   Second Intervention
    Azithromycin (Test) First     Zithromax® (Reference) First  
STARTED     39     39  
COMPLETED     39     39  
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
Azithromycin (Test) First Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
Zithromax® (Reference) First Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
    Azithromycin (Test) First     Zithromax® (Reference) First     Total  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     40     79  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     18     22     40  
Male     22     18     40  
Race/Ethnicity, Customized  
[units: Participants]
     
White     38     35     73  
Black     2     2     4  
Asian     0     1     1  
Native American     0     2     2  
Region of Enrollment  
[units: participants]
     
United States     40     40     80  



  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 168 hour period ]

2.  Primary:   AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 168 hour period ]

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)   [ Time Frame: Blood samples collected over 168 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


Responsible Party: Vice President Global Generic Biopharmaceutics, TEVA Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00830206     History of Changes
Other Study ID Numbers: R05-1430
Study First Received: January 26, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board