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Desmopressin Acetate 0.2 mg Tablets, Fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835211
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Desmopressin Acetate 0.2 mg Tablets
Drug: DDAVP® 0.2 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
Desmopressin Acetate Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
DDAVP® DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

Period 1:   First Intervention
    Desmopressin Acetate   DDAVP®
STARTED   24   24 
COMPLETED   24   23 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 2:   Washout: 7 Days
    Desmopressin Acetate   DDAVP®
STARTED   24   23 
COMPLETED   21   22 
NOT COMPLETED   3   1 
Adverse Event                2                1 
Withdrawal by Subject                1                0 

Period 3:   Second Intervention
    Desmopressin Acetate   DDAVP®
STARTED   21   22 
COMPLETED   21   22 
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
Desmopressin Acetate Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
DDAVP® DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
   Desmopressin Acetate   DDAVP®   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   48 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   24   24   48 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   12   6   18 
Male   12   18   30 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   22   20   42 
Hispanic   2   2   4 
Black   0   2   2 
Region of Enrollment 
[Units: Participants]
     
Canada   24   24   48 


  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 12 hour period ]

2.  Primary:   AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 12 hour period ]

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)   [ Time Frame: Blood samples collected over 12 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



ClinicalTrials.gov Identifier: NCT00835211     History of Changes
Other Study ID Numbers: AA04887
Study First Received: January 30, 2009
Results First Received: June 30, 2009
Last Updated: September 1, 2009
Health Authority: Canada: Ethics Review Committee