Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01439230 | Donepezil 10 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 36 | — | — | Jun 1, 2007 | Aug 1, 2007 | Sep 23, 2011 | 1 | Canada |
| NCT01439243 | Donepezil 10 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 26 | — | — | Jun 1, 2007 | Jul 1, 2007 | Sep 23, 2011 | 1 | Canada |
| NCT01260922 | 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions. | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2006 | May 1, 2006 | Feb 21, 2011 | 1 | United States |
| NCT01260948 | 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2006 | May 1, 2006 | Feb 21, 2011 | 1 | United States |
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Donepezil AUC0-72 (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Donepezil 10 mg Tablets |
| Reference Listed Drug | ACTIVE_COMPARATOR | Aricept® 10 mg Tablets |
| Name | Type | Description |
|---|---|---|
| Donepezil | DRUG | 10 mg Tablet |
| Aricept® | DRUG | 10 mg Tablet |
| Donepezil Hydrochloride | DRUG | 10 mg Orally Disintegrating Tablet |
Inclusion Criteria: * Male or female, non-smoker, \> 18 and \< 55 years of age. * Capable of consent. * BMI \> 19.0 and \< 27.0. * Good state of health (no clinically significant deviations from normal clinical results and laboratory test findings. Exclusion Criteria: * Absence of any inclusion c...