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Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01124175
First received: May 13, 2010
Last updated: November 22, 2010
Last verified: November 2010
Results First Received: June 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Losartan
Drug: Cozaar®

  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
Losartan (Test) First 100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
Cozaar® (Reference) First 100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Losartan (Test) First   Cozaar® (Reference) First
STARTED   40   40 
COMPLETED   40   40 
NOT COMPLETED   0   0 

Period 2:   Washout of 7 Days
    Losartan (Test) First   Cozaar® (Reference) First
STARTED   40   40 
COMPLETED   40   38 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                2 

Period 3:   Second Intervention
    Losartan (Test) First   Cozaar® (Reference) First
STARTED   40   38 
COMPLETED   40   38 
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
Losartan (Test) First 100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
Cozaar® (Reference) First 100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
   Losartan (Test) First   Cozaar® (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   37   38   75 
>=65 years   3   2   5 
Gender 
[Units: Participants]
     
Female   13   23   36 
Male   27   17   44 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   3   2   5 
Caucasian   36   35   71 
Hispanic   1   3   4 
Region of Enrollment 
[Units: Participants]
     
Canada   40   40   80 


  Outcome Measures
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1.  Primary:   Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 24 hour period. ]

2.  Primary:   AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 24 hour period. ]

3.  Primary:   AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 24 hour period. ]

4.  Secondary:   Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 24 hour period. ]

5.  Secondary:   AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 24 hour period. ]

6.  Secondary:   AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 24 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



Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01124175     History of Changes
Other Study ID Numbers: 30273
Study First Received: May 13, 2010
Results First Received: June 21, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee