RESEARCH

https://cpt.snu.ac.kr/en/Research/Achievment/NewDrugDevelopment URL COPY

Department of Clinical Pharmacology and Therapeutics of Seoul National University college of Medicine and Hospital contributes to successful clinical development of new drugs through conducting clinical trials and consultation of clinical trials development.

  • 2022

    Envlo Tab. -
    Daewoong Pharmaceutical Co., Ltd.Oral hypoglycemic agent

  • 2021

    Fexuclue Tab. -
    Daewoong Pharmaceutical Co., Ltd.Antiulcer

  • 2018

    K-CAB Tab. -
    HK inno.N CorporationAntiulcer

  • 2015

    SUGANON – Dong-A ST Co.,LtdOral Hypoglycemic Agent

  • 2012

    ZEMIGLO - LG Life Sciences, LtdAntidiabetics

  • 2010

    KANARB -
    Boryung Pharmaceutical Co., Ltd.Antihypertensive agents

※ Click on the product above
to see the relevant clinical trial details.

연구성과
Approved year Product name Active ingredient Efficacy Company
2022 Envlo Tab. Enavogliflozin Oral hypoglycemic agent Daewoong Pharmaceutical Co., Ltd.
2021 Fexuclue Tab. Fexuprazan Antiulcer Daewoong Pharmaceutical Co., Ltd.
2018 K-CAB Tab. Tegoprazan Antiulcer HK inno.N Corporation
2015 SUGANON Evogliptin tartrate Oral hypoglycemic agent Dong-A ST Co.,Ltd
2015 Sivextro Injection Tedizolid phosphate Antibiotics Dong-A ST Co.,Ltd
2013 DUVIE Tablet Lobeglitazone sulfate Antidiabetics Chong Kun Dang Pharmaceutical Corp.
2012 Gemigliptin Tablet Gemigliptn Tartrate Sesquihydrate, Metformin Hydrocholoride Antidiabetics LG Chem, Ltd
2011 PYRAMAX Pyronaridone, Altesunate Antimalarial agent Shinpoong Pharm.co.,LTd
2010 Kanarb Tablet Fimasartan Potassium Trihydrate Antihypertensive agents Boryung Pharmaceutical Co.,Ltd.
2007 MVIX TAB. Mirodenafil Erectile dysfunction agent SK Discovery Co.
2005 ZYDENA Tablet Undenafil Erectile dysfunction agent Dong-A ST Co.,Ltd
2005 REVANEX Revaprazan Antiulcer Yuhan Corporation
2002 Factive Tablet Gemigliptn Tartrate Sesquihydrate Antibiotics LG Chem, Ltd
2001 Q-ROXIN TAB. Balofloxacin Antibiotics JW Pharmaceutical
close

2022

Envlo Tab. - Daewoong Pharmaceutical Co., Ltd.
Oral hypoglycemic agent

신약 임상개발 성공사례 - 엔블로정
No Title Year NCT No
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

2021

Fexuclue Tab. - Daewoong Pharmaceutical Co., Ltd.
Antiulcer

신약 임상개발 성공사례 - 펙수클루정
No Title Year NCT No
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

2018

K-CAB Tab. - HK inno.N Corporation
Antiulcer

신약 임상개발 성공사례 - 케이캡정
No Title Year NCT No
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

2015

SUGANON – Dong-A ST Co.,Ltd
Oral Hypoglycemic Agent

신약 임상개발 성공사례 - 슈가논정
No Title Year NCT No
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

2012

ZEMIGLO - LG Life Sciences, Ltd
Antidiabetics

No Title Year NCT No
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

2010

KANARB - Boryung Pharmaceutical Co., Ltd.
Antihypertensive agents

No Title Year NCT No
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