Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01260922
First received: December 14, 2010
Last updated: January 24, 2011
Last verified: January 2011
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind
Condition: Healthy
Interventions: Drug: Donepezil Hydrochloride
Drug: Aricept®

  Participant Flow
  Hide 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
Donepezil Hydrochloride (Test) First 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
Aricept® (Reference) First 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Donepezil Hydrochloride (Test) First     Aricept® (Reference) First  
STARTED     13     13  
COMPLETED     13     12  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 2:   Washout of 28 Days
    Donepezil Hydrochloride (Test) First     Aricept® (Reference) First  
STARTED     13     12  
COMPLETED     9     10  
NOT COMPLETED     4     2  
Withdrawal by Subject                 4                 2  

Period 3:   Second Intervention
    Donepezil Hydrochloride (Test) First     Aricept® (Reference) First  
STARTED     9     10  
COMPLETED     9     8  
NOT COMPLETED     0     2  
Emesis                 0                 2  



  Baseline Characteristics
  Hide 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
Donepezil Hydrochloride (Test) First 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
Aricept® (Reference) First 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Donepezil Hydrochloride (Test) First     Aricept® (Reference) First     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     7     9     16  
Male     6     4     10  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic     1     0     1  
Caucasian     12     13     25  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax of Donepezil.   [ Time Frame: Blood samples collected over a 72 hour period. ]

2.  Primary:   AUC0-t of Donepezil.   [ Time Frame: Blood samples collected over a 72 hour period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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


No publications provided


Responsible Party: Associate Director, Biopharmaceutics, TEVA Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260922     History of Changes
Other Study ID Numbers: R05-1254
Study First Received: December 14, 2010
Results First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board