Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840216
First received: February 6, 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: Drug: Clarithromycin ER 500 mg tablets
Drug: BIAXIN® XL 500 mg tablets

  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
Clarithromycin (Test) First Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
Biaxin® (Reference) First Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Clarithromycin (Test) First     Biaxin® (Reference) First  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

Period 2:   Washout: 7 Days
    Clarithromycin (Test) First     Biaxin® (Reference) First  
STARTED     11     11  
COMPLETED     10     11  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 3:   Second Intervention
    Clarithromycin (Test) First     Biaxin® (Reference) First  
STARTED     10     11  
COMPLETED     10     11  
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
Clarithromycin (Test) First Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
Biaxin® (Reference) First Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
Total Total of all reporting groups

Baseline Measures
    Clarithromycin (Test) First     Biaxin® (Reference) First     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     1     1     2  
Gender  
[units: participants]
     
Female     5     6     11  
Male     6     5     11  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     9     10     19  
Black     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 36 hour period ]

2.  Primary:   AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 36 hour period ]

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration   [ Time Frame: Blood samples collected over 36 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


No publications provided


ClinicalTrials.gov Identifier: NCT00840216     History of Changes
Other Study ID Numbers: 02198
Study First Received: February 6, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board