초록 ▼

본 연구의 목표는 도네페질을 주성분으로 하는 치매치료용 패취의 2상 혹은 3상의 IND 승인을 받기 위해 임상 1상 단회투여 및 반복투여 시험을 완료하고 임상3상의 임상시험승인을 받는 것이다.

1. 임상1상 단회투여 : 건강한 남성 자원자에서 Donepezil patch 제제 단회투여 시의 안전성/내약성 및 약동학 특성 평가
2. 임상2상 반복투여 : 건강한 남성 자원자에서 Donepezil patch 제제 반복투여 시의 안전성/내약성 및 약동학 특성 평가
3. 경구제와 패치제의 PK 시뮬레이션 연구
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본 연구의 목표는 도네페질을 주성분으로 하는 치매치료용 패취의 2상 혹은 3상의 IND 승인을 받기 위해 임상 1상 단회투여 및 반복투여 시험을 완료하고 임상3상의 임상시험승인을 받는 것이다.

1. 임상1상 단회투여 : 건강한 남성 자원자에서 Donepezil patch 제제 단회투여 시의 안전성/내약성 및 약동학 특성 평가
2. 임상2상 반복투여 : 건강한 남성 자원자에서 Donepezil patch 제제 반복투여 시의 안전성/내약성 및 약동학 특성 평가
3. 경구제와 패치제의 PK 시뮬레이션 연구

위와 같은 임상 1상 시험을 완료하였으며 이를 토대로 경구제와 패치제의 PK 비교 시뮬레이션을 진행임상 3상의 synopsis를 개발하였으며 임상시험계획신청서를 11월내에 제출할 계획이다.

Abstract ▼

I. Purpose of Necessity of the research
Dementia is an aged-associated disease in modern society increasing sharply aging population as well as expected to confront serious health problem in a century. It is categorized into Alzheimer’ s disease and vascular dementia. Widely taken donepezil oral

I. Purpose of Necessity of the research
Dementia is an aged-associated disease in modern society increasing sharply aging population as well as expected to confront serious health problem in a century. It is categorized into Alzheimer’ s disease and vascular dementia. Widely taken donepezil oral tablet for dementia treatment is one of the reversible inhibitor of the enzyme acetylcholinesterase breaking down acetylcholine to increase the amounts of acetylcholine at synapse cleft of cholinergic system. We have changed administration’ s route of donepezil to transdermal absorption so that it is to reduce side effects occurring in the oral medication such as liver and digestive function disorder and improve patient’ s compliance from development of dosage form continuously releasing drug.
We ended non-clinical study about donepezil patch at the time of starting this trial and have proceeded phase 1 single and multiple dose study through this project. In addition, we have proceeded PK simulation to entry above clinical trials.

Ⅱ. Detail and scope of the research
1) Production for clinical trial patch (for SAD, MAD test)
2) Study of performance test and modification of dosage form
3) A phase 1 single dose trial
4) A phase 1 multiple dose trial
5) High-level IND application and approval

Ⅲ. Results of the research
1) Production for clinical trial patch: produce the patch for each SAD (single administration dose) and MAD (multiple administration dose) test
2) Study of performance test and modification of dosage form (patch performance test and long term, accelerated stability test: performance test of produced patch, 18 months long term and 6 months accelerated stability assurance
3) A phase 1 single dose trial: safety and pharmacokinetics assessment of single dose in healthy subjects
4) A phase 1 multiple dose trial: safety and pharmacokinetics assessment of multiple dose in healthy subjects
5) High-level IND application and approval: schedule to start a phase 3 clinical trial without a phase 2 study. a phase 3 protocol development

Ⅳ. Application plan of research results
Submit a phase 3 clinical trial protocol of donepezil patch using the data of a phase 1 study and PK simulation New formulation of transdermal is available from other drug, which has similar medicinal characteristics, by a slight variation.