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Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00836056
First received: February 3, 2009
Last updated: September 1, 2009
Last verified: September 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: Clindamycin 300 mg capsule
Drug: Cleocin HCl 300 mg capsules

  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
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Reporting Groups
  Description
Clindamycin (Test) First Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
Cleocin® (Reference) First Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period

Participant Flow for 3 periods

 Period 1:   First Intervention
    Clindamycin (Test) First     Cleocin® (Reference) First  
STARTED     12     12  
COMPLETED     11     12  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Washout: 7 Days
    Clindamycin (Test) First     Cleocin® (Reference) First  
STARTED     11     12  
COMPLETED     11     12  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Clindamycin (Test) First     Cleocin® (Reference) First  
STARTED     11     12  
COMPLETED     11     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Clindamycin (Test) First Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
Cleocin® (Reference) First Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
    Clindamycin (Test) First     Cleocin® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     8     6     14  
Male     4     6     10  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Caucasian     12     12     24  
Region of Enrollment  
[units: participants]
 		     
Canada     12     12     24  



  Outcome Measures
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1.  Primary:   Bioequivalence Based on Cmax   [ Time Frame: Blood samples collected over 24 hour period ]
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2.  Primary:   Bioequivalence Based on AUCinf   [ Time Frame: Blood samples collected over 24 hour period ]
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3.  Primary:   Bioequivalence Based on AUC0-t   [ Time Frame: Blood samples collected over 24 hour period ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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: NCT00836056     History of Changes
Other Study ID Numbers: 30312
Study First Received: February 3, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: Canada: Ethics Review Committee