초록

1일1회1정 복용하는 고지혈증 및 당뇨병 치료용 서방성 복합제(로수바스타틴/메트포르민)를 개발하여 임상1상 (단회투여 식이영향시험)을 통해 생물학적 동등성을 확보하였으며, 임상3상승인완료하였음.

(출처 : 보고서 요약서 3p)

Abstract ▼

Purpose & Contents
Purpose : The purpose of the project is to develop a once-daily fixed-dose combinations of rosuvastatin and metformin for hyperlipidemia and diabetes mellitus and to enter subsequent clinical trials by establishing bioequivalence through phase I study, consisting of pharmacokin

Purpose & Contents
Purpose : The purpose of the project is to develop a once-daily fixed-dose combinations of rosuvastatin and metformin for hyperlipidemia and diabetes mellitus and to enter subsequent clinical trials by establishing bioequivalence through phase I study, consisting of pharmacokinetic evaluations of single-dose and food effect study.
Contents:
1. Technology transfer (from R&D to Manufacturing) and Pilot scale production
- Technology transfer of manufacturing process and scale-up production
- Manufacture and Stability studies (accelerated & long-term testing) of investigational product
2. Preclinical study
- single-dose toxicity study/ dose range finding (DRF) study (for 4weeks).
- 13 weeks repeated dose toxicity study
3. Phase I clinical trial (single dose and food effect study)
- Protocol development of phase I clinical trial
- IND approval for Phase I clinical trials
- Selection of CRO and clinical trial center
- Initiation and completion of phase I trial
4. Phase Ⅲ clinical trial
- Protocol development of phase III clinical trial
- IND approval for phase Ⅲ clinical trial

Results
1. Technology transfer (from R&D to Manufacturing) and Pilot scale production
- Completion in Technology transfer of manufacturing process and scale-up production
- Completion in manufacture and Stability studies (accelerated & long-term testing) of investigational product
2. Preclinical Study
- Completion in single-dose toxicity study/ dose range finding (DRF) study (for 4weeks).
- Completion in 13 weeks of repeat-dose toxicity study
3. Phase I clinical trial (single dose and food effect study)
- Initiation and completion of phase I clinical trial
4. Phase Ⅲ clinical trial
- Completion in IND approval for phase Ⅲ clinical trial

Expected Contribution
○ A once-daily fixed-dose combination (FDC) of rosuvastatin and metformin can improve medication compliance. This is especially useful for patients with multiple chronic diseases that require reduced burden in drug administration.
○ FDC can reduce in statin-induced side effects such as myopathy. This can ultimately lead to improved quality of life in patients.
○ New patents can secure market exclusivity and protect new technology.
○ Provide an effective and ideal treatment to elderly patients with complication of multiple diseases.
○ Drug delivery system (DDS) formulation technology has application potential to many drugs on the market around the world.

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• CONTENTS ... 6
• 목차 ... 7
• 1. 연구개발과제의 개요 ... 8
• 1-1. 연구개발 목적 ... 8
• 1-2. 연구개발의 필요성 ... 8
• 1-3. 연구개발 범위 ... 14
• 2. 국내외 기술개발 현황 ... 17
• 3. 연구수행 내용 및 결과 ... 19
• 4. 목표달성도 및 관련분야 기여도 ... 29
• 5. 연구결과의 활용계획 ... 30
• 6. 연구과정에서 수집한 해외과학기술정보 ... 30
• 7. 연구개발성과의 보안등급 ... 32
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 32
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 32
• 10. 연구개발과제의 대표적 연구실적 ... 33
• 11. 기타사항 ... 33
• 12. 참고문헌 ... 33
• 별첨 ... 35
• 끝페이지 ... 38