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Trial record 56 of 853 for:    tablet | Japan

Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01119443
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 27, 2011
Last Update Posted : June 9, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Intervention: Drug: PPX ER

  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
Treatment Sequence A 1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
Treatment Sequence B 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted

Participant Flow for 7 periods

Period 1:   Up-titration Period (10 Days)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   14 
COMPLETED   14   14 
NOT COMPLETED   0   0 

Period 2:   Crossover Period 1 (5 Days)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   14 
COMPLETED   14   13 
NOT COMPLETED   0   1 
Adverse Event                0                1 

Period 3:   Crossover Period 2 (5 Days)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 

Period 4:   Crossover Period 3 (5 Days)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 

Period 5:   Crossover Period 4 (5 Days)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 

Period 6:   Down-titration Period (1 Day)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 

Period 7:   End of Study (All Patients)
    Treatment Sequence A   Treatment Sequence B
STARTED   14   14 
COMPLETED   14   14 
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
Treatment Sequence A 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
Treatment Sequence B 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
Total Total of all reporting groups

Baseline Measures
   Treatment Sequence A   Treatment Sequence B   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.2  (4.8)   29.1  (5.4)   29.1  (5.0) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   14   14   28 


  Outcome Measures

1.  Primary:   AUCτ,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

2.  Primary:   Cmax,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

3.  Primary:   AUCτ,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

4.  Primary:   Cmax,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

5.  Secondary:   Cτ,ss (Fed Conditions)   [ Time Frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration ]

6.  Secondary:   Cmin,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

7.  Secondary:   Tmax,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

8.  Secondary:   λz,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

9.  Secondary:   t1/2,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

10.  Secondary:   MRTpo,ss (Fed Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

11.  Secondary:   Cτ,ss (Fasted Conditions)   [ Time Frame: pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration ]

12.  Secondary:   Cmin,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

13.  Secondary:   Tmax,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

14.  Secondary:   λz,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

15.  Secondary:   t1/2,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]

16.  Secondary:   MRTpo,ss (Fasted Conditions)   [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration ]


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01119443     History of Changes
Other Study ID Numbers: 248.677
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: May 30, 2011
Results First Posted: June 27, 2011
Last Update Posted: June 9, 2014