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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
| Arm | Type | Description |
|---|---|---|
| Donepezil Hydrochloride Tablets, 23 mg | EXPERIMENTAL | Donepezil Hydrochloride Tablets, 23 mg of Dr.Reddy's Laboratories Ltd |
| Aricept | ACTIVE_COMPARATOR | Aricept® 23 mg tablet of Eisai Inc |
| Donepezil Hydrochloride10 mg Tablets | EXPERIMENTAL | Donepezil Hydrochloride 10 mg Tablets of Dr. Reddy's Laboratories Limited |
| Aricept 10 mg Tablets | ACTIVE_COMPARATOR | Aricept 10 mgTablets of Pfizer Inc |
| Name | Type | Description |
|---|---|---|
| Donepezil | DRUG | Donepezil Hydrochloride tablets,23 mg |
| Donepezil Hydrochloride | DRUG | Donepezil Hydrochloride Tablets 10 mg |
| Aricept | DRUG | Aricept 10 mg Tablets |
Inclusion Criteria: 1. Male or female volunteer 2. Volunteer aged of at least 18 years but not older than 45 years 3. Volunteer with a body mass index (BMI) greater than or equal to 21 and below 30 kg/m2 4. Volunteer with a body weight greater than or equal to 60 kg. 5. Light-, non- or ex-smokers. ...
Donepezil is a small molecule drug developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It is currently in Phase 1 clinical development. The listed trials for Donepezil are bioavailability and bioequivalence studies conducted in healthy volunteers, evaluating tablet formulations of 10 mg and 23 mg under fasting and fed conditions.
Donepezil targets ACHE, also known as acetylcholinesterase. It acts as an inhibitor of this enzyme. By inhibiting ACHE, Donepezil affects cholinergic signaling. This molecular target is the basis for its pharmacological activity.
Donepezil is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is responsible for the clinical development of Donepezil.
Donepezil is in Phase 1 clinical development. All four listed trials are Phase 1 studies, and all are completed. There are currently no active trials for Donepezil among the listed studies.
Donepezil has been studied in four completed Phase 1 trials: NCT01923558, NCT01923259, NCT01504516, and NCT01504503. These trials evaluated bioavailability or bioequivalence of Donepezil hydrochloride tablets in healthy volunteers in Canada and India, with a total enrollment of 221 participants.
Yes, Donepezil is also known as Donepezil Hydrochloride. The clinical trials listed for Donepezil specifically refer to Donepezil Hydrochloride tablets, including 10 mg and 23 mg formulations. The two names refer to the same active substance.