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Trial record 5 of 118 for:    URSODIOL

Ursodiol 500 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00909753
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 2009
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: Ursodiol
Drug: Urso Forte™

  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
Ursodiol (Test) First Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
Urso Forte™ (Reference) First Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.

Participant Flow for 3 periods

Period 1:   Period: First Intervention
    Ursodiol (Test) First   Urso Forte™ (Reference) First
STARTED   46   46 
COMPLETED   46   46 
NOT COMPLETED   0   0 

Period 2:   Period: Washout of 28 Days
    Ursodiol (Test) First   Urso Forte™ (Reference) First
STARTED   46   46 
COMPLETED   44   43 
NOT COMPLETED   2   3 
Protocol Violation                2                3 

Period 3:   Period: Second Intervention
    Ursodiol (Test) First   Urso Forte™ (Reference) First
STARTED   44   43 
COMPLETED   43   43 
NOT COMPLETED   1   0 
Protocol Violation                1                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
Ursodiol (Test) First Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
Urso Forte™ (Reference) First Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
Total Total of all reporting groups

Baseline Measures
   Ursodiol (Test) First   Urso Forte™ (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   46   92 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   46   46   92 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   13   17   30 
Male   33   29   62 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   31   33   64 
Black   13   11   24 
Asian   2   2   4 
Region of Enrollment 
[Units: Participants]
     
Canada   46   46   92 


  Outcome Measures

1.  Primary:   Cmax - Maximum Observed Concentration - for Total Ursodiol   [ Time Frame: Blood samples collected over 72 hour period ]

2.  Primary:   AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol   [ Time Frame: Blood samples collected over 72 hour period ]

3.  Primary:   Cmax for Unconjugated Ursodiol   [ Time Frame: Blood samples collected over 72 hour period ]

4.  Primary:   AUC0-72 for Unconjugated Ursodiol   [ Time Frame: Blood samples collected over 72 hour period ]

5.  Primary:   Cmax for Total Ursodiol - Baseline Corrected   [ Time Frame: Blood samples collected over 72 hour period ]

6.  Primary:   AUC0-72 for Total Ursodiol - Baseline Corrected   [ Time Frame: Blood samples collected over 72 hour period ]

7.  Primary:   Cmax for Unconjugated Ursodiol - Baseline Corrected   [ Time Frame: Blood samples collected over 72 hour period ]

8.  Primary:   AUC0-72 for Unconjugated Ursodiol - Baseline Corrected   [ Time Frame: Blood samples collected over 72 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: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com



ClinicalTrials.gov Identifier: NCT00909753     History of Changes
Other Study ID Numbers: 2006-1284
First Submitted: May 26, 2009
First Posted: May 28, 2009
Results First Submitted: June 12, 2009
Results First Posted: July 21, 2009
Last Update Posted: August 20, 2009