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Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01074463
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : April 30, 2010
Last Update Posted : April 30, 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
Intervention: Drug: Pramipexole Dihydrochloride

  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
Test (Pramipexole Dihydrochloride) First 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
Reference (Mirapex®) First 0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Test (Pramipexole Dihydrochloride) First   Reference (Mirapex®) First
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 

Period 2:   Washout of 7 Days
    Test (Pramipexole Dihydrochloride) First   Reference (Mirapex®) First
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Test (Pramipexole Dihydrochloride) First   Reference (Mirapex®) First
STARTED   12   12 
COMPLETED   12   12 
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
Test (Pramipexole Dihydrochloride) First 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
Reference (Mirapex®) First 0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
   Test (Pramipexole Dihydrochloride) First   Reference (Mirapex®) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   12   24 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   5   7   12 
Male   7   5   12 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   10   12   22 
Black   1   0   1 
Native American   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

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

3.  Primary:   AUC0-inf (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



ClinicalTrials.gov Identifier: NCT01074463     History of Changes
Other Study ID Numbers: R04-1203
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: April 8, 2010
Results First Posted: April 30, 2010
Last Update Posted: April 30, 2010