Trial Outcomes & Findings for 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions. (NCT NCT01260922)
NCT ID: NCT01260922
Last Updated: 2011-02-21
Results Overview
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Blood samples collected over a 72 hour period.
Results posted on
2011-02-21
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
13
|
|
First Intervention
COMPLETED
|
13
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout of 28 Days
STARTED
|
13
|
12
|
|
Washout of 28 Days
COMPLETED
|
9
|
10
|
|
Washout of 28 Days
NOT COMPLETED
|
4
|
2
|
|
Second Intervention
STARTED
|
9
|
10
|
|
Second Intervention
COMPLETED
|
9
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
1
|
|
Washout of 28 Days
Withdrawal by Subject
|
4
|
2
|
|
Second Intervention
Emesis
|
0
|
2
|
Baseline Characteristics
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
Baseline characteristics by cohort
| Measure |
Donepezil Hydrochloride (Test) First
n=13 Participants
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
n=13 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Donepezil Hydrochloride (Test)
n=17 Participants
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
|
Aricept® (Reference)
n=17 Participants
10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Donepezil.
|
17800.27 ng/mL
Standard Deviation 4515.36
|
17280.23 ng/mL
Standard Deviation 4032.57
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Donepezil Hydrochloride (Test)
n=17 Participants
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
|
Aricept® (Reference)
n=17 Participants
10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Donepezil.
|
466307.49 ng*h/mL
Standard Deviation 85094.55
|
490716.21 ng*h/mL
Standard Deviation 86199.11
|
Adverse Events
Donepezil Hydrochloride (Test) First
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Aricept® (Reference) First
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Donepezil Hydrochloride (Test) First
n=26 participants at risk
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
n=26 participants at risk
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.
|
|---|---|---|
|
General disorders
Headache
|
11.5%
3/26 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
|
General disorders
Nausea
|
19.2%
5/26 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
15.4%
4/26 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
|
General disorders
Vomiting
|
19.2%
5/26 • Number of events 13 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
11.5%
3/26 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
|
General disorders
Dizziness
|
0.00%
0/26 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
7.7%
2/26 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
|
General disorders
Abnormal Dreams
|
7.7%
2/26 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
0.00%
0/26 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
|
General disorders
Feeling Hot
|
7.7%
2/26 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
0.00%
0/26 • Adverse event data was collected over the course of the study, which was approximately 8 weeks in duration.
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.
|
Additional Information
Associate Director, Biopharmaceutics
Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER