Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Dr. Reddy's Laboratories Ltd for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies focused on bioequivalence and bioavailability in healthy subjects.
Donepezil is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is conducting Phase 1 clinical trials to evaluate the drug's bioequivalence and bioavailability in healthy volunteers.
Donepezil is in Phase 1 clinical development. All four clinical trials associated with the drug have been completed, with a total enrollment of 221 healthy volunteers across studies in India and Canada.
Donepezil has four completed Phase 1 trials: NCT01504503 and NCT01504516 for 10 mg tablets under fasting and fed conditions in India, and NCT01923259 and NCT01923558 for 23 mg tablets under fed and fasting conditions in Canada.
Donepezil is an investigational drug still in clinical development. It is currently in Phase 1 trials, and no approval status has been indicated. The drug is being studied in healthy volunteers for bioequivalence and bioavailability purposes.