Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Donepezil · 4 trials · 1 indication
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...
Donepezil is being studied in healthy volunteers in Phase 1 clinical trials. These trials evaluate 10 mg donepezil hydrochloride orally disintegrating tablets and 10 mg donepezil tablets under fasting and fed conditions. The studies are conducted in the United States and Canada.
Donepezil is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of donepezil in healthy volunteers.
Donepezil is in Phase 1 clinical development. All four clinical trials listed for donepezil are Phase 1 studies, and all have been completed. The drug is investigational and not yet approved for any use.
Donepezil has four completed Phase 1 trials: NCT01260922 and NCT01260948 test 10 mg orally disintegrating tablets under fasting and non-fasting conditions in the US, while NCT01439230 and NCT01439243 test 10 mg tablets under fasting and fed conditions in Canada.
Donepezil is the base form of the drug, while donepezil hydrochloride is the salt form used in the clinical trials. The trials evaluate 10 mg donepezil hydrochloride orally disintegrating tablets and 10 mg donepezil tablets.