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0 Trials |  |
5 News |  |
- | donepezil sustained release / Generic mfg.
Preclinical, Journal: Establishment of Level a In Vitro-In Vivo Correlation (IVIVC) via Extended DoE-IVIVC Model: A Donepezil Case Study. (Pubmed Central) - Jun 25, 2022
The in vitro dissolution patterns of donepezil SR tablets were described by Michaelis-Menten kinetics...The present extended DoE-IVIVC model may provide a valuable tool to predict the effect of formulation changes on in vivo pharmacokinetic behavior, leading to the more efficient development of SR formulations. The application of the present modeling approaches to develop other forms of drug formulation may be of interest for future studies.
- || donepezil sustained release / Generic mfg.
PK/PD data, Preclinical, Journal: Pharmacokinetic Evaluation of a Novel Donepezil-Loaded Dissolving Microneedle Patch in Rats. (Pubmed Central) - Jan 26, 2022
The DMN arrays also effectively increased drug permeation and demonstrated sustained release and absorption of donepezil from DMN patches. These patches allow extended dosing intervals, reduced gastrointestinal adverse effects, and convenient self-administration to mitigate poor drug compliance, making them beneficial for the treatment of elderly patients with Alzheimer's disease.
- || donepezil sustained release / Generic mfg.
Clinical data, Journal, Real-world evidence: Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer's disease. (Pubmed Central) - May 16, 2021
P3
Trial simulation using RWD could be a valuable tool for post-market comparative effectiveness studies and for informing future trials' design. Nevertheless, such an approach may be limited, for example, by the availability of RWD that matches the target trials of interest, and further investigations are warranted.
- ||||| donepezil sustained release / Generic mfg.
Enrollment change: Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease (clinicaltrials.gov) - Jan 1, 2013
P3, N=1467, Completed, Sponsor: Eisai Inc.
Nevertheless, such an approach may be limited, for example, by the availability of RWD that matches the target trials of interest, and further investigations are warranted. N=1200 --> 1467
- | donepezil sustained release / Generic mfg., donepezil / Generic mfg.
Trial completion: A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia (clinicaltrials.gov) - Dec 26, 2012
P2, N=40, Completed, Sponsor: Eisai Co., Ltd.
N=1200 --> 1467 Active, not recruiting --> Completed
- ||||||| donepezil sustained release / Generic mfg.
Trial completion: Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease (clinicaltrials.gov) - Oct 30, 2011
P3, N=915, Completed, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| donepezil sustained release / Generic mfg.
Enrollment change: Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease (clinicaltrials.gov) - Oct 27, 2011
P3, N=915, Completed, Sponsor: Eisai Inc.
Active, not recruiting --> Completed N=1200 --> 915