Daclatasvir Dihydrochloride

Deskripsyon kout:

Non API a Endikasyon Spesifikasyon US DMF Inyon Ewopeyen DMF KEP
Daclatasvir Dihydrochloride HCV Nan kay la    


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Deskripsyon

Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) se yon pisan ak oralman aktif.HCV NS5A pwoteyininhibiteur akEC50s ranje 9-146 pM pouplizyè jenotip replikon HCV.Daclatasvir dihydrochloride se tou yonòganik anyon transpòte polipèptid 1B (OATP1B)epiOATP1B3inhibiteur akIC50s nan 1.5 µM ak 3.27 µM, respektivman.

IC50& Sib

EC50: 50 pM (HCV replicon jenotip 1a), 9 pM (HCV replicon jenotip 1b), 71 pM (HCV replicon jenotip 2a), 146 pM (HCV replicon jenotip 3a), 12 pM (HCV replicon jenotip 4a) ak HCV replicon jenotip 5a)[1]
Kd: 8 nM (NS5A33-202) ak 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) ak 3.27 µM (OATP1B3)[3]

In vitro

Daclatasvir (BMS-790052) demontre aktivite inhibitor ki pisan nan direksyon pou tout jenotip yo teste, ak EC.50valè ki sòti nan 9 pM a 146 pM.Daclatasvir inibit HCV replicon jenotip 1a, 1b, 2a, 3a, 4a ak 5a ak EC50valè 50 pM, 9 pM, 71 pM, 146 pM, 12 pM ak 33 pM, respektivman.Daclatasvir se yon inibitè ki pisan nan viris enfektye JFH-1 jenotip 2a ki repwodui nan kilti selilè (EC).50= 28 pM)[1].Daclatasvir (BMS-790052) mare byen sere nan NS5A33-202 ak NS5A26-202 ak K.ds nan 8 nM ak 210 nM, respektivman[2].

Depo

Poud

-20°C

3 zan
 

4°C

2 zan
Nan sòlvan

-80°C

6 mwa
 

-20°C

1 mwa


Esè klinik

Nimewo NCT Sponsor Kondisyon Dat Kòmanse

Faz

NCT03369327 Tehran University of Medical Sciences|RojanPharma Pharmaceutical Company Enfeksyon Viris Epatit C, Repons a Terapi |Viris Iminodefisyans Imèn 1ye janvye 2017

Faz 3

NCT03485846 R-Pharm|Almedis Epatit C kwonik jenotip 1b 27 novanm 2017

Faz 2

NCT01016912 Bristol-Myers Squibb Enfeksyon epatit C Desanm 2009

Faz 2

NCT01629732 Bristol-Myers Squibb Viris Epatit C Mas 2013

Faz 2

NCT01497834 Bristol-Myers Squibb Epatit C Janvye 2012

Faz 3

NCT01973049 Bristol-Myers Squibb Epatit C Desanm 2013

Faz 3

NCT00663208 Bristol-Myers Squibb Epatit C kwonik Me 2008

Faz 2

NCT02576314 Sant rechèch limanite ak sante|Beijing 302 Lopital Enfeksyon kwonik epatit C Me 2015

Faz 3

NCT02756936 Genuine Research Center, peyi Lejip|Zeta Pharmaceutical Industries An sante Fevriye 2016

Faz 1

NCT02771405 National Hepatology & Tropical Medicine Research Institute|Cairo University Epatit C, Kwonik|Kansòm epatoselilè Mas 2016

Faz 3

NCT03706898 Viriom VIH-1-enfeksyon|Defisyans Epatik 1ye oktòb 2018

Faz 1

NCT02319031 Bristol-Myers Squibb Epatit C Fevriye 2015

Faz 3

NCT02124044 National Institutes of Health Clinical Center (CC)|Enstiti Nasyonal pou Alèji ak Maladi Enfektye (NIAID)|Bristol-Myers Squibb VIH-HCV Fevriye 2014

Faz 2

NCT02551861 Bristol-Myers Squibb Epatit C Desanm 2015

Faz 2

NCT00859053 Bristol-Myers Squibb Ensifizans epatik Mas 2009

Faz 1

NCT01257204 Bristol-Myers Squibb Viris Epatit C Desanm 2010

Faz 2

NCT03063879 Tehran University of Medical Sciences|Ahvaz Jundishapur University of Medical Sciences|Shiraz University of Medical Sciences|University of Medical Sciences Hamadan Epatit C, Kwonik | Ensifizans Renal Kwonik 1ye avril 2017

Faz 4

NCT01017575 Bristol-Myers Squibb Enfeksyon epatit C Desanm 2009

Faz 2

NCT02865369 Sang Gyune Kim|Seoul National University Boramae Hospital|Severance Hospital|Inha University Hospital|Korea University|Gachon University Gil Medical Center|Hanyang University Seoul Hospital|Ewha Womans University Mokdong Hospital|Bristol-Myers Squibb|Soonchunhyang University Hospital Epatit C kwonik Septanm 2016

NCT04070235 Nanjing Sanhome famasetik, co, Ltd. Epatit C, kwonik 29 mas 2019

Faz 2| Faz 3

NCT03487848 Bristol-Myers Squibb Epatit C|Epatit kwonik 18 me 2018

Faz 2

NCT00904059 Bristol-Myers Squibb Epatit C Me 2009

Faz 1

NCT02107365 Enstiti nasyonal franse pou sante ak rechèch medikal-Ajans nasyonal franse pou rechèch sou SIDA ak epatit viral (Inserm-ANRS)|Bristol-Myers Squibb Epatit C Viris Jenotip 4 Enfeksyon Novanm 2013

Faz 2

NCT02397395 Janssen R&D Iland Enfimite Renal|Maladi Renal Etap Fen Me 2015

Faz 2

NCT03169348 Inivèsite Assiut Epatit C 1ye novanm 2017

Pa aplikab

NCT02323594 Bristol-Myers Squibb Enfeksyon epatit C Desanm 2014

Faz 1

NCT03537196 Enstiti nasyonal franse pou sante ak rechèch medikal-Ajans nasyonal franse pou rechèch sou SIDA ak epatit viral (Inserm-ANRS) Epatit C|Itilize dwòg|Epatit C viral 13 novanm 2018

Faz 4

NCT02103569 Bristol-Myers Squibb Epatit C Avril 2014

Faz 1

NCT02772744 Zagazig University|Kairo University Epatit C 1ye novanm 2017

NCT01718158 Bristol-Myers Squibb Epatit C Janvye 2013

Faz 3

NCT02496078 Bristol-Myers Squibb Epatit C Out 2015

Faz 3

NCT01425970 Bristol-Myers Squibb Epatit C Me 2012

Faz 2

NCT01471574 Bristol-Myers Squibb Epatit C, jenotip 1 Desanm 2011

Faz 3

NCT01573351 Bristol-Myers Squibb Viris Epatit C Me 2012

Faz 3

NCT01938625 Janssen R&D Iland Epatit C, kwonik 12 desanm 2013

Faz 2

NCT01492426 Bristol-Myers Squibb Epatit C Janvye 2012

Faz 3

NCT03480932 Johns Hopkins Bloomberg School of Public Health|National Institute on Drug Abuse (NIDA)|YR Gaitonde Center for AIDS Research and Education Epatit C, kwonik 2 fevriye 2018

Faz 2| Faz 3

NCT03163849 Inivèsite Assiut Epatit kwonik c 1ye septanm 2019

Faz 3

NCT01581203 Bristol-Myers Squibb Viris Epatit C Me 2012

Faz 3

NCT01492504 Bristol-Myers Squibb Epatit C 7 fevriye 2012

NCT03686722 Mohamed Raslan|Ain Shams University|Drog Research Center, Cairo, Egypt Dyabèt Melito, Kalite 2|Epatit C|Entèaksyon Medikaman 9 septanm 2017

Faz 1

NCT02262728 Janssen Research & Development, LLC Epatit C, kwonik 30 septanm 2014

Faz 2

NCT02349048 Janssen Research & Development, LLC Viris Epatit C Janvye 2015

Faz 2

NCT03882307 Inivèsite Assiut Epatit C, kwonik Me 2020

Faz bonè 1

NCT02758509 Parc de Salut Mar Epatit C kwonik | Siwoz 1ye janvye 2010

NCT01795911 Bristol-Myers Squibb Epatit C Mas 2013

Faz 2

NCT03549832 Assiut University|Sohag University|South Valley University Koinfeksyon HCV 1ye janvye 2018

Pa aplikab

NCT02161939 Bristol-Myers Squibb Epatit C kwonik  

NCT01309932 Bristol-Myers Squibb Epatit C Mas 2011

Faz 2

NCT01995266 Bristol-Myers Squibb Epatit C 28 fevriye 2014

Faz 3

NCT02640157 AbbVie Epatit C Kwonik|Viris Epatit C|Jenotip 3 Viris Epatit C Desanm 2015

Faz 3

NCT02032875 Bristol-Myers Squibb Epatit C Mas 2014

Faz 3

NCT02624063 Inivèsite Federal São Paulo Epatit C, kwonik Desanm 2015

Faz 4

NCT00546715 Bristol-Myers Squibb Epatit C kwonik Novanm 2007

Faz 1 | Faz 2

NCT01718145 Bristol-Myers Squibb Enfeksyon Viris Epatit C Novanm 2012

Faz 3

NCT01616524 Bristol-Myers Squibb Viris Epatit C (HCV) Jiyè 2012

Faz 3

NCT02032901 Bristol-Myers Squibb Epatit C Janvye 2014

Faz 3

NCT03540212 Inivèsite Ain Shams Enfeksyon kwonik HCV 10 desanm 2017

Faz 2| Faz 3

NCT02097966 Bristol-Myers Squibb Epatit C kwonik  

NCT02596880 Teheran University of Medical Sciences Epatit C | Siwoz Septanm 2015

Faz 3

NCT04019717 Atea Pharmaceuticals, Inc. Epatit C|Epatit C, Kwonik|Epatit C kwonik|Enfeksyon Viris Epatit C|Enfeksyon HCV 20 jen 2019

Faz 2

NCT02992457 Tanta Inivèsite Epatit C Janvye 2015

Faz 4

NCT03547895 Inivèsite Zagazig Siwoz dekonpanse 1ye jen 2015

Pa aplikab

NCT03004625 Kaohsiung Medical University Chung-Ho Memorial Hospital|Chang Gung Memorial Hospital|National Taiwan University Hospital|Taipei Veterans General Hospital, Taiwan|China Medical University Hospital|National Cheng-Kung University Hospital Epatit C Novanm 2016

Faz 3

NCT01051414 Bristol-Myers Squibb Enfeksyon epatit C Avril 2010

Faz 2

NCT02309450 Enstiti nasyonal franse pou sante ak rechèch medikal-Ajans nasyonal franse pou rechèch sou SIDA ak epatit viral (Inserm-ANRS)|Bristol-Myers Squibb Epatit C Viris Jenotip 4 Enfeksyon Desanm 2014

Faz 2

NCT01628692 Bristol-Myers Squibb|Janssen Research & Development, LLC Viris Epatit C Jiyè 2012

Faz 2

NCT03186313 Lopital fwa moun peyi Lejip|Wadi El Nil Hospital Epatit C Septanm 2016

Faz 3

NCT03063723 Twazyèm Lopital Afilye, Inivèsite Sun Yat-Sen Epatit C kwonik (Trouble) 1ye janvye 2016

NCT00983957 Bristol-Myers Squibb Epatit C kwonik Oktòb 2009

Faz 1

NCT01725542 Enstiti nasyonal franse pou sante ak rechèch medikal-Ajans nasyonal franse pou rechèch sou SIDA ak epatit viral (Inserm-ANRS)|Bristol-Myers Squibb Ko-enfeksyon HCV-VIH Desanm 2012

Faz 2

NCT02282709 Fondasyon pou rechèch nan fwa Epatit C kwonik Fevriye 2014

Faz 3

NCT02032888 Bristol-Myers Squibb Epatit C Fevriye 2014

Faz 3

NCT03247296 Inivèsite MTI Epatit C 28 fevriye 2017

NCT01389323 Bristol-Myers Squibb Epatit C Septanm 2011

Faz 3

NCT02556086 Bristol-Myers Squibb Epatit C Desanm 2015

Faz 2

NCT01741545 Bristol-Myers Squibb Viris Epatit C 31 mas 2013

Faz 3

NCT01866930 Bristol-Myers Squibb Enfeksyon kwonik epatit C 11 jiyè 2013

Faz 3

NCT02268864 Janssen-Cilag International NV Epatit C, kwonik Janvye 2015

Faz 2

NCT01797848 Bristol-Myers Squibb Epatit C jen 2014

Faz 3

NCT03166280 Eman Sayed Hassan Abd Allah|Assiut University Epatit C jen 2017

NCT02159352 Bristol-Myers Squibb Epatit C jen 2014

Faz 1

NCT01125189 Bristol-Myers Squibb Viris Epatit C Jiyè 2010

Faz 2

NCT03748745 Nanjing Sanhome famasetik, co, Ltd. Entèaksyon Dwòg 19 novanm 2018

Faz 1

NCT01012895 Bristol-Myers Squibb Epatit C kwonik Desanm 2009

Faz 2

NCT02565888 Inivèsite Radboud Epatit C|VIH Novanm 2015

Faz 1

NCT02555943 Sant rechèch limanite ak sante|Beijing 302 Hospital|Nanfang Hospital nan Southern Medical University Enfeksyon Epatit C kwonik|Koenfeksyon HBV|Reaktivasyon Epatit B Fevriye 2015

Faz 2| Faz 3

NCT02304159 Tarek I. Hassanein, MD, FACP, FAG, AGAF|Southern California Research Center Epatit C | Siwoz Janvye 2015

Faz 4

NCT02580474 Myeong Jun Song|Bristol-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam National University Hospital|Konyang University Hospital|Eulji University Hospital|Saint Vincent´s Hospital, Kore di|Konkuk University Hospital|Cheongju St. Mary´s Hospital, Cheongju , Kore|Lopital Severance|Kore di Inivèsite Guro Hospital|Eulji General Hospital|The Catholic University of Korea Epatit C Fevriye 2016

Faz 4

NCT02104843 Bristol-Myers Squibb Epatit C Avril 2014

Faz 1

NCT01428063 Bristol-Myers Squibb Enfeksyon Viris Epatit C Septanm 2011

Faz 2

NCT02123654 Bristol-Myers Squibb Enfeksyon Viris Epatit C Avril 2014

Faz 3

NCT02565862 Inivèsite Radboud Epatit C|Dyabèt melitu|Rezistans ensilin Janvye 2016

Faz 1

NCT04211844 Inivèsite Ain Shams Epatit C kwonik 1ye oktòb 2019

NCT00874770 Bristol-Myers Squibb Enfeksyon epatit C jen 2009

Faz 2

NCT03883698 Sanjay Gandhi Postgraduate Institute of Medical Sciences Ensifizans ren, Kwonik|Epatit C 15 mas 2019

Faz 3

NCT01448044 Bristol-Myers Squibb Epatit C Desanm 2011

Faz 3

NCT01359644 Bristol-Myers Squibb|Pharmasset Epatit C kwonik jen 2011

Faz 2

NCT01842451 Vertex Pharmaceuticals Incorporated Epatit C kwonik|CHC|HCV|Epatit C jen 2013

Faz 2

NCT02762448 Lopital Minisipal Tainan Epatit c Jiyè 2016

NCT02473211 Sant rechèch limanite ak sante|Beijing 302 Lopital Enfeksyon kwonik epatit C Janvye 2015

Faz 2| Faz 3

NCT01455090 Bristol-Myers Squibb Epatit C kwonik 30 novanm 2011

Faz 2

NCT03490097 Inivèsite Ain Shams Epatit kwonik c|Sendwòm metabolik 1ye desanm 2017

Faz 2| Faz 3

NCT01170962 Bristol-Myers Squibb Viris Epatit C Out 2010

Faz 2

NCT02333292 Hospital Universitario Valme|Hospital del SAS de Jerez|Hospital General Universitario Elche|Hospital La Línea de la Concepción|Complexo Hospitalario Universitario de A Coruña|Hospital de Figueres|Hospital Universitario Puerto Real|Hospital Universitario Virgen de la Victoria|Hospital Universitario de Canarias| Hospital General Universitario de Alicante|Hospital Universitario Araba|Hospital Royo Vilanova|Hospital Universitario de Burgos|Complejo Hospitalario Universitario de Huelva|Hospital Universitario Reina Sofia de Cordoba|Hospital Universitario Virgen Macarena|Complexo Hospitalario Universitario de Vigo|Clinica Universidad de Navarra, Universidad de Navarra|Hospital Clinico Universitario San Cecilio|Hospital Universitario La Fe|Hospital General Universitario de Valencia|Hospital Universitario Infanta Leonor|Hospital Universitario de Gran Canaria|Hospital General Universitario Santa Lucía|Centro Penitenciario Alicante 1|Hospital Regional Universitario Carlos Haya|Hospital Virgen de la Luz|Lopital Jeneral Universitario de Castellón|Lopital Parc Taulí, Sabadell Enfeksyon kwonik epatit C Desanm 2014

NCT03200184 Teheran University of Medical Sciences Epatit C 1ye septanm 2016

Faz 4

NCT03188276 Twazyèm Lopital Afilye, Inivèsite Sun Yat-Sen Epatit C kwonik 1ye fevriye 2016

Faz bonè 1

NCT01830205 Bristol-Myers Squibb Epatit C Septanm 2012

Faz 1

 

SÈTIFIKA

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

JESYON BON JAN KALITE

Quality management1

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Quality management2

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Quality management3

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Quality management4

Ekip Pwofesyonèl Afè Regilasyon sipòte demann kalite yo pandan aplikasyon an ak enskripsyon an.

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