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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01923259 | Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition | PHASE1 | COMPLETED | 94 | — | — | Oct 1, 2010 | Dec 1, 2010 | Aug 15, 2013 | 1 | Canada |
| NCT01923558 | Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fasting Condition | PHASE1 | COMPLETED | 76 | — | — | Oct 1, 2010 | Nov 1, 2010 | Aug 15, 2013 | 1 | Canada |
| NCT01504503 | Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition | PHASE1 | COMPLETED | 26 | — | — | Oct 1, 2009 | Dec 1, 2009 | Jan 6, 2012 | 1 | India |
| NCT01504516 | Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition | PHASE1 | COMPLETED | 25 | — | — | Oct 1, 2009 | Dec 1, 2009 | Jan 6, 2012 | 1 | India |
| 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. ...