RESEARCH

https://cpt.snu.ac.kr/kr/Research/Achievment/NewDrugDevelopment 주소복사

서울대학교 의과대학 임상약리학교실은 임상시험 및 임상개발자문 등을 통해 성공적인 신약 임상개발에 기여하고 있습니다.

  • 2022년

    엔블로정-㈜대웅제약경구용 혈당 강하제

  • 2021년

    펙수클루정-㈜대웅제약위산분비억제제

  • 2018년

    케이캡정-에이치케이이노엔㈜위산분비억제제

  • 2015년

    슈가논정-동아에스티㈜경구용 혈당 강하제

  • 2012년

    제미글로정 – ㈜LG생명과학당뇨병 치료제

  • 2010년

    카나브정-보령제약㈜고혈압치료제

※ 위 제품을 클릭하면 관련된 임상시험 내역을 확인하실 수 있습니다.

연구성과
허가연도 제품명 주성분 효능·효과 회사명
2022 엔블로정 이나보글리플로진 경구용 혈당 강하제 (주)대웅제약
2021 펙수클루정 펙수프라잔 위산분비억제제 (주)대웅제약
2018 케이캡정 테고프라잔 위산분비억제제 에이치케이이노엔(주)
2015 슈가논정 에보글립틴 타르타르산염 경구용 혈당 강하제 동아에스티(주)
2015 시벡스트로정 테디졸리드포스페이트 항균제(항생제) 동아에스티(주)
2013 듀비에정 로베글리타존 황산염 당뇨병치료제 (주)종근당
2012 제미글로정 제미글립틴타르타르산염 1.5수화물 당뇨병치료제 (주)LG화학
2011 피라맥스정 피로나리딘인산염, 알테수네이트 말라리아치료제 신풍제약(주)
2010 카나브정 피마살탄칼륨삼수화물 고혈압치료제 보령제약(주)
2007 엠빅스정 미로데나필염산염 발기부전치료제 SK케미칼(주)
2005 자이데나정 유데나필 발기부전치료제 동아제약(주)
2005 레바넥스정 레바프라잔 항궤양제 (주)유한양행
2003 슈도박신주 건조정제슈도모나스백신 농구균예방백신 CJ제일제당(주)
2002 팩티브정 메탄설폰산제미플록사신 항균제(항생제) (주)LG화학
2001 큐록신정 발로플록사신 항균제(항생제) JW중외제약(주)
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2022년

엔블로정 - (주)대웅제약
경구용 혈당 강하제

신약 임상개발 성공사례 - 엔블로정
연번 임상시험 제목 수행년도 NCT번호
1 A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male Volunteers 2017 NCT03364985
2 A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults 2019 NCT04064073
3 A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment (Phase 1c) 2020 NCT04221399
4 A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults 2020 NCT04343547
5 An open-label, single-center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics 2022 NCT05207176
6 An open-label, multi-center, parallel, single oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function 2023 NCT05747664

2021년

펙수클루정 - (주)대웅제약
위산분비억제제

신약 임상개발 성공사례 - 펙수클루정
연번 임상시험 제목 수행년도 NCT번호
1 A dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation phase 1 clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers 2016 NCT02757144
2 A randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects 2018 NCT03487562
3 A single-center, phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP14012 in healthy Japanese, Caucasian and Korea 2018 NCT03574415
4 A randomized, open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers 2020 NCT04490434
5 A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects 2022 NCT05812404
6 A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects 2022 NCT05574374
7 A randomized, open-label study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of drug-drug interactions between DWP14012 and Aspirin in healthy subjects 2022 NCT05304845

2018년

케이캡정 - 에이치케이이노엔(주)
위산분비억제제

신약 임상개발 성공사례 - 케이캡정
연번 임상시험 제목 수행년도 NCT번호
1 A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers 2017 NCT03378284
2 A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects 2018 NCT03530228
3 A randomized, open-label, three-period, multiple dosing crossover clinical trial to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes in healthy male volunteers 2019 NCT03814642
4 A randomized, open-label, single-dose phase 1 clinical trial to compare the effect of timing of food on the pharmacokinetics and pharmacodynamics of K-CAB (tegoprazan) in healthy male subjects 2019 NCT03863938
5 An open label, randomized, single and multiple dosing phase I clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN C005 after oral administration in healthy Korean and Caucasian male subjects 2020 NCT04485884
6 An open-label, randomized, crossover study to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers 2020 NCT04231136
7 A randomized, open-label, multiple dosing, cross-over phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects 2021 NCT05005065
8 A randomized, open-label, three-period, multiple dosing crossover clinical trial to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel in healthy subjects 2023 NCT06164834

2015년

슈가논정 - 동아에스티(주)
경구용 혈당 강하제

신약 임상개발 성공사례 - 슈가논정
연번 임상시험 제목 수행년도 NCT번호
1 A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects 2009 NCT00961025
2 Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects 2013 NCT01941199
3 PK/PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients 2014 NCT02214693
4 A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers 2014 NCT02167061
5 A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers 2015 NCT02375139
6 Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg 2016 NCT02753803
7 Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg 2016 NCT02954822

2012년

제미글로정 - ㈜LG생명과학
당뇨병 치료제

연번 임상시험 제목 수행년도 NCT번호
1 A dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, and pharmacokinetics/pharmacodynamics of LC15-0444 Tartrate after oral administration in healthy male subjects 2006
2 Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects 2009 NCT01001013
3 Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects 2011 NCT01426399
4 BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone 2012 NCT01595880
5 BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone 2012 NCT01662674
6 BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone 2015 NCT02670070

2010년

카나브정-보령제약(주)
고혈압치료제

연번 임상시험 제목 수행년도 NCT번호
1 A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers 2009 NCT00991705
2 A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers 2009 NCT00991783
3 A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers 2009 NCT00938197
4 A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers 2009 NCT00923533
5 A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers 2009 NCT00938262
6 A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers 2009 NCT00938132
7 A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers 2010 NCT01148368
8 A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide 2014 NCT02222480
9 Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers 2015 NCT02397590
10 A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects 2016 NCT02920047
11 A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers 2016 NCT02994745