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10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT01260922
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : February 21, 2011
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single
Condition Healthy
Interventions Drug: Donepezil Hydrochloride
Drug: Aricept®
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Hydrochloride (Test) First Aricept® (Reference) First
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 13 13
Completed 13 12
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Washout of 28 Days
Started 13 12
Completed 9 10
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             4             2
Period Title: Second Intervention
Started 9 10
Completed 9 8
Not Completed 0 2
Reason Not Completed
Emesis             0             2
Arm/Group Title Donepezil Hydrochloride (Test) First Aricept® (Reference) First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
7
  53.8%
9
  69.2%
16
  61.5%
Male
6
  46.2%
4
  30.8%
10
  38.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic 1 0 1
Caucasian 12 13 25
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Cmax of Donepezil.
Hide Description Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Time Frame Blood samples collected over a 72 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Donepezil Hydrochloride (Test) Aricept® (Reference)
Hide Arm/Group Description:
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
17800.27  (4515.36) 17280.23  (4032.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil Hydrochloride (Test), Aricept® (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 102.16
Confidence Interval (2-Sided) 90%
97.07 to 107.51
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t of Donepezil.
Hide Description Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time Frame Blood samples collected over a 72 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Donepezil Hydrochloride (Test) Aricept® (Reference)
Hide Arm/Group Description:
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
466307.49  (85094.55) 490716.21  (86199.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil Hydrochloride (Test), Aricept® (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Slope
Estimated Value 94.75
Confidence Interval (2-Sided) 90%
92.11 to 97.46
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.
Time Frame Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
Adverse Event Reporting Description Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
 
Arm/Group Title Donepezil Hydrochloride (Test) First Aricept® (Reference) First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Donepezil Hydrochloride (Test) First Aricept® (Reference) First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Hydrochloride (Test) First Aricept® (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Donepezil Hydrochloride (Test) First Aricept® (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/26 (38.46%)      6/26 (23.08%)    
General disorders     
Headache * 1  3/26 (11.54%)  3 1/26 (3.85%)  1
Nausea * 1  5/26 (19.23%)  5 4/26 (15.38%)  5
Vomiting * 1  5/26 (19.23%)  13 3/26 (11.54%)  4
Dizziness * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
Abnormal Dreams * 1  2/26 (7.69%)  2 0/26 (0.00%)  0
Feeling Hot * 1  2/26 (7.69%)  2 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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 Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Biopharmaceutics
Organization: Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
Responsible Party: Associate Director, Biopharmaceutics, TEVA Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260922     History of Changes
Other Study ID Numbers: R05-1254
First Submitted: December 14, 2010
First Posted: December 15, 2010
Results First Submitted: January 24, 2011
Results First Posted: February 21, 2011
Last Update Posted: February 21, 2011