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Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01149486
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : September 14, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Interventions: Drug: Losartan potassium/Hydrochlorothiazide
Drug: Hyzaar®

  Participant Flow

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/HCTZ (Test) First 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
Hyzaar® (Reference) First 100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Losartan/HCTZ (Test) First   Hyzaar® (Reference) First
STARTED   10   10 
COMPLETED   10   9 
NOT COMPLETED   0   1 
Adverse Event                0                1 

Period 2:   Washout of 7 Days
    Losartan/HCTZ (Test) First   Hyzaar® (Reference) First
STARTED   10   9 
COMPLETED   10   9 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Losartan/HCTZ (Test) First   Hyzaar® (Reference) First
STARTED   10   9 
COMPLETED   10   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

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/HCTZ (Test) First 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
Hyzaar® (Reference) First 100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
   Losartan/HCTZ (Test) First   Hyzaar® (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   8   9   17 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian   1   1   2 
Black   0   1   1 
Caucasian   9   8   17 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 48 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 48 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 48 hour period. ]

4.  Primary:   Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 48 hour period. ]

5.  Primary:   AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 48 hour period. ]

6.  Primary:   AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 48 hour period. ]

7.  Secondary:   Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 48 hour period. ]

8.  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 48 hour period. ]

9.  Secondary:   AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 48 hour period. ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: NCT01149486     History of Changes
Other Study ID Numbers: R04-080
First Submitted: June 21, 2010
First Posted: June 23, 2010
Results First Submitted: August 16, 2010
Results First Posted: September 14, 2010
Last Update Posted: December 8, 2010