Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01020877
First received: November 24, 2009
Last updated: June 21, 2010
Last verified: June 2010
Results First Received: February 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Intervention: Drug: Metronidazole

  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
Test (Metronidazole) First 0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
Reference (MetroGel-Vaginal®) First 0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Test (Metronidazole) First     Reference (MetroGel-Vaginal®) First  
STARTED     19     19  
COMPLETED     19     19  
NOT COMPLETED     0     0  

Period 2:   Washout of 7 Days
    Test (Metronidazole) First     Reference (MetroGel-Vaginal®) First  
STARTED     19     19  
COMPLETED     19     19  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Test (Metronidazole) First     Reference (MetroGel-Vaginal®) First  
STARTED     19     19  
COMPLETED     18     19  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 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
Test (Metronidazole) First 0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
Reference (MetroGel-Vaginal®) First 0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Test (Metronidazole) First     Reference (MetroGel-Vaginal®) First     Total  
Number of Participants  
[units: participants]
  19     19     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     19     38  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     19     19     38  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Black     4     8     12  
Caucasian     13     11     24  
More Than One     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     19     19     38  



  Outcome Measures
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1.  Primary:   Cmax (Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 60 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 60 hour period. ]

3.  Primary:   AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 60 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: Associate Director, Biopharmaceutics
Organization: TEVA Pharmaceuticals, USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01020877     History of Changes
Other Study ID Numbers: 10136019
Study First Received: November 24, 2009
Results First Received: February 22, 2010
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board