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Label indication NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized… FDA label
Also known as donepezil hydrochloride, Aricept®
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 a small molecule drug being studied for cognitive impairment. It is an acetylcholinesterase (ACHE) inhibitor. Teva Pharmaceutical Industries Limited is developing it, and the clinical program described here consists of Phase 1 trials in healthy volunteers rather than in patients with cognitive impairment.
Donepezil targets acetylcholinesterase, also known as ACHE. It belongs to the inhibitor class, meaning it acts by inhibiting this enzyme. This mechanism is the basis for its investigation in cognitive impairment, though the trials listed here were conducted in healthy volunteers rather than in patients.
Donepezil is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is the sponsor of the Phase 1 trials listed for this asset, including studies conducted in Canada and the United States.
Donepezil is in Phase 1 development for cognitive impairment. All four listed trials are Phase 1 studies, and all four are completed, with no active trials currently listed. The studies enrolled healthy volunteers rather than patients.
Four completed Phase 1 trials are listed for donepezil: NCT01439243 and NCT01439230, both run in Canada under fed and fasting conditions respectively, and NCT01260948 and NCT01260922, both run in the United States and testing orally disintegrating tablets under non-fasting and fasting conditions.
Yes. Donepezil is also known as donepezil hydrochloride, and the two names refer to the same drug. Some of the listed trials, including NCT01260948 and NCT01260922, use the donepezil hydrochloride name in their titles while studying orally disintegrating tablets.