Doxycycline Hyclate

Maikling Paglalarawan:

Pangalan ng API Indikasyon Pagtutukoy US DMF EU DMF CEP
Doxycycline Hyclate Mga antibiotic USP/EP 13771  


Detalye ng Produkto

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DETALYE NG PRODUKTO

Background

Ang Doxycycline hyclate ay isang antibiotic [1].

Ang Doxycycline hyclate ay isang derivative ng tetracycline at nagtataglay ng mga aktibidad ng anti-inflammatory at antimicrobial.Pinipigilan ng Doxycycline ang pagtitiklop ng dengue virus sa vitro sa paraang nakadepende sa temperatura.Ang halaga ng IC50 ay 52.3μM sa 37°C at 26.7μM sa 40°C.Pinipigilan nito ang dengue virus sa pamamagitan ng pagpigil sa NS2B-NS3 serine protease ng virus.Binabawasan ng 60μM doxycycline ang CPE ng mga cell na nahawahan ng DNEV2 [1].

Ang Doxycycline ay natagpuan na isang inhibitor ng MMP.Ang paggamot sa doxycycline ay binabawasan ang mga antas ng MMP-8 at -9 at pinipigilan ang pagpapahayag ng tissue na MMP-2 at MMP-9.Bukod dito, ang paggamot na may doxycycline ay makabuluhang binabawasan ang saklaw ng intracranial aneurysms.Ang Doxycycline ay naiulat din na isang anti-inflammatory agent batay sa pagsugpo nito sa matrix metalloproteinases.Bilang karagdagan, ang doxycycline ay may makapangyarihang aktibidad na antimalarial na may halaga ng IC50 na 320nM sa 96h in vitro [2, 3].

Mga sanggunian:
[1] Rothan HA, Mohamed Z, Paydar M, Rahman NA, Yusof R. Inhibitory effect ng doxycycline laban sa dengue virus replication in vitro.Arko Virol.2014 Abr;159(4):711-8.
[2] Maradni A, Khoshnevisan A, Mousavi SH, Emamirazavi SH, Noruzijavidan A. Tungkulin ng matrix metalloproteinases (MMPs) at MMP inhibitors sa intracranial aneurysms: isang review na artikulo.Med J Islam Repub Iran.2013 Nob;27(4):249-254.
[3] Draper MP, Bhatia B, Assefa H, Honeyman L, Garrity-Ryan LK, Verma AK, Gut J, Larson K, Donatelli J, Macone A, Klausner K, Leahy RG, Odinecs A, Ohemeng K, Rosenthal PJ, Nelson ML.In vitro at in vivo antimalarial efficacies ng optimized tetracyclines.Mga Ahente ng Antimicrob Chemother.2013 Hul;57(7):3131-6.

Paglalarawan

Ang Doxycycline (hyclate) (Doxycycline hydrochloride hemiethanolate hemihydrate), isang antibiotic, ay isang oral active at broad-spectrum metalloproteinase (MMP) inhibitor[1].

Klinikal na Pagsubok

Numero ng NCT Sponsor Kundisyon Petsa ng Pagsisimula

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NCT00246324 Louisiana State University Health Sciences Center Shreveport|Biogen Multiple sclerosis Disyembre 2003

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Phase 3

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Phase 2

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Phase 4

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Phase 1

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Phase 4

NCT00012688 US Department of Veterans Affairs|Colgate-Periogard-Dentsply|VA Office of Research and Development Diabetes Mellitus|Mahinang Glycemic Control|Peridontal Disease  

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Phase 4

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Phase 4

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Phase 3

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Phase 2

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Phase 1

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Phase 2

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Phase 2

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Phase 2

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Maagang Phase 1

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Phase 2

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Phase 4

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Phase 2

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Phase 4

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Phase 1

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Phase 2

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Phase 4

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Phase 4

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Phase 3

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Phase 2

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Phase 3

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Phase 4

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Phase 2

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Phase 3

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Phase 4

NCT04310930 The University of Queensland|Australian Government Department of Health|Children's Hospital Foundation|Cystic Fibrosis Foundation|Newcastle University|Griffith University|Erasmus Medical Center|Monash University|University of Copenhagen|Hôpital Cochin|South Australian Health and Medical Research Institute|University ng Melbourne|James Cook University, Queensland, Australia|Murdoch Childrens Research Institute Sakit sa Pulmonary Dahil sa Mycobacteria (Diagnosis) Marso 2020

Phase 2|Phase 3

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Phase 1

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Phase 4

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Phase 3

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Phase 3

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Phase 3

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Phase 3

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Phase 2

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Phase 3

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NCT00803842 Northwestern University Hindi Maliit na Cell Lung Cancer Oktubre 2008

Hindi maaari

NCT02086591 Unibersidad ng Rochester Adult Diffuse Large B-Cell Lymphoma|Paulit-ulit na Mantle Cell Lymphoma|Lymphoma, Follicular|Marginal Zone B-Cell Lymphoma|Malignant Lymphoma - Lymphoplasmacytic|Waldenstrom Macroglobulinemia|Small Lymphocytic Lymphoma|Chronic Lymphocytic Lymphoma-CLLocytic Leukemia Marso 2014

Phase 2

NCT03980223 University of California, San Francisco|University of Washington|National Institute of Allergy and Infectious Diseases (NIAID)|Mayne Pharma International Pty Ltd|San Francisco Department of Public Health Gonorrhea|Chlamydia|Syphilis Nobyembre 26, 2019

Phase 4

NCT00355459 University of Texas Southwestern Medical Center Dry Eye Syndrome Agosto 2005

Hindi maaari

NCT01254799 Omar Mamdouh Shaaban|Assiut University Pagdurugo ng Uterine Enero 2008

Phase 3

NCT01547325 NanoSHIFT LLC|Departamento ng Depensa ng Estados Unidos Dehisced Surgical Wounds Mayo 2012

Hindi maaari

NCT00653380 Par Pharmaceutical, Inc.|Anapharm Upang Matukoy ang Bioequivalence sa ilalim ng mga Kondisyon ng Pag-aayuno Setyembre 1999

Phase 1

NCT00635609 Warner Chilcott Acne Vulgaris Marso 2008

Phase 4

NCT03765931 Institut de Recherche pour le Development Lagnat Hulyo 2016

Phase 4

NCT01160640 Harold Wiesenfeld|National Institute of Allergy and Infectious Diseases (NIAID)|University of Pittsburgh Pelvic Inflammatory Disease Nobyembre 2010

Phase 2

NCT01756833 Unibersidad ng Maryland, Baltimore|National Institute on Aging (NIA) Aneurysm Mayo 2013

Phase 2

NCT00688064 Galderma Malubhang Acne Vulgaris Agosto 2008

Phase 3

NCT01320033 Galderma Acne Vulgaris Marso 29, 2011

Phase 2

NCT03397004 St. Michael's Hospital, Toronto|Barrow Neurological Institute|Duke University|Feinstein Institute for Medical Research|University of Pittsburgh|Sunnybrook Health Sciences Center Hereditary Hemorrhagic Telangiectasia (HHT) Setyembre 12, 2018

Phase 2

NCT01635530 Turku University Hospital Lyme Neuroborreliosis Agosto 2012

Phase 4

NCT03727620 Unibersidad ng Mohammed V Souissi Agresibong Periodontitis Enero 6, 2014

Phase 1|Phase 2

NCT02688738 Rothman Institute Orthopedics Propionibacterium Marso 2015

Hindi maaari

NCT00358462 Unibersidad ng Washington|National Institute of Allergy and Infectious Diseases (NIAID) Urethritis Enero 2007

Phase 3

NCT02864550 British Columbia Center para sa Pagkontrol ng Sakit Syphilis|Mga Impeksyon na Naililipat sa Sekswal Agosto 15, 2019

Phase 4

NCT01595594 Unibersidad ng Sao Paulo|Fundação de Amparo à Pesquisa do Estado de São Paulo Periodontal Disease|Type 2 Diabetes Marso 2010

Phase 3

NCT00964834 PharmAthene, Inc.|National Institutes of Health (NIH)|Medarex|Quintiles, Inc.|Department of Health at Human Services Anthrax Hulyo 2009

Phase 1

NCT01809444 Unibersidad ng Sun Yat-sen Mga Opthalmopathies na Kaugnay ng Thyroid Nobyembre 2012

Phase 2|Phase 3

NCT01590082 MD Anderson Cancer Center|National Institutes of Health (NIH)|National Cancer Institute (NCI) Melanoma Nobyembre 2012

Phase 1|Phase 2

NCT00207584 Mga Sentro para sa Pagkontrol at Pag-iwas sa Sakit Mycoplasma Pneumoniae Enero 1994

Hindi maaari

NCT00775177 Ranbaxy Laboratories Limited|Ranbaxy Inc. Malusog Hunyo 2005

Hindi maaari

NCT03462329 University Medical Center Ljubljana Erythema Migrans Hunyo 1, 2018

Hindi maaari

NCT00000403 Indiana University|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|National Institute on Aging (NIA) Osteoarthritis Setyembre 1996

Phase 3

NCT03508232 Unibersidad ng Alberta|Royal Alexandra Hospital ST Segment Elevation Myocardial Infarction|Pagkabigo sa Puso Enero 6, 2020

Phase 2

NCT02553473 Ospital ng Sorlandet HF Neuroborreliosis, Borrelia Burgdorferi Oktubre 2015

Phase 3

NCT02207556 Kolehiyo ng Medikal ng Wisconsin Pangunahing Systemic Amyloidosis Oktubre 1, 2014

Phase 2

NCT01783106 Royal Liverpool University Hospital|National Association for Colitis and Crohn's Disease|National Institute for Health Research, United Kingdom Sakit ni Crohn Pebrero 1, 2014

Phase 2

NCT00353743 Hospital de Clinicas de Porto Alegre Aborsyon, Septic Mayo 2006

Hindi maaari

NCT01727973 Unibersidad ng Sun Yat-sen Graves Ophthalmopathy|Graves Disease|Mga Sakit sa Mata|Mga Sakit sa Thyroid|Mga Sakit sa Endocrine System|Mga Sakit sa Mata, Namamana|Hyperthyroidism|Mga Sakit sa Autoimmune|Mga Sakit sa Immune System Oktubre 2012

Phase 1|Phase 2

NCT00857038 Medical Center Alkmaar|Leiden University Medical Center|University of Amsterdam Talamak na Obstructive Pulmonary Disease|Pamamamaga|Pulmonary Emphysema Abril 2009

Phase 4

NCT02774993 National University Hospital, Singapore|Tan Tock Seng Hospital|National University, Singapore|A*Star Tuberkulosis Setyembre 2015

Phase 2

NCT03474458 IRCCS Policlinico S. Matteo Cardiac AL Amyloidosis Pebrero 11, 2019

Phase 2|Phase 3

NCT02874430 Sidney Kimmel Cancer Center sa Thomas Jefferson University|Thomas Jefferson University Breast Carcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Uterine Corpus Cancer|Uterine Corpus Carcinosarcoma Hunyo 8, 2016

Phase 2

NCT00016835 Unibersidad ng Michigan|National Institute of Dental and Craniofacial Research (NIDCR) Sakit sa Periodontal|Diabetes Mellitus, Type 2 Oktubre 17, 2001

Phase 2

NCT00064766 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pagdurugo ng Endometrial|Periodontal Disease Pebrero 2003

Phase 4

NCT00803452 Unibersidad ng Louisville Blepharitis Hulyo 2008

Phase 4

NCT01434173 Bayer|RTI Health Solutions Pinsala sa Atay na Dahil sa Droga Hulyo 2001

NCT00126204 Barnes-Jewish Hospital Aortic Aneurysm Marso 2004

Hindi maaari

NCT01917721 Hawaii Pacific Health Sakit sa Kawasaki|Coronary Aneurysm Oktubre 2013

Phase 2

NCT02775695 Kolehiyo ng Medikal ng Wisconsin Resectable Pancreatic Cancer Abril 3, 2017

Phase 2

NCT03824340 Ospital ng Aljazeera kawalan ng katabaan Enero 30, 2019

Hindi maaari

NCT01847976 Ottawa Hospital Research Institute|Canadian Breast Cancer Foundation Sakit Agosto 2013

Phase 2

NCT02850913 Makerere University|University of Oxford Mga seizure Setyembre 5, 2016

Phase 2

NCT00764361 NanoSHIFT LLC Ulcer sa Paa ng Diabetic Enero 2009

Phase 2

NCT02036528 Royer Biomedical, Inc. Mga Ulser sa Paa ng Diabetic Enero 2014

Phase 1|Phase 2

NCT01661985 Ostergotland County Council, Sweden|Statens Serum Institut Urethritis|Cervicitis|Genital Mycoplasma Infection|Chlamydia Trachomatis Pebrero 2010

Phase 4

NCT01380483 Par Pharmaceutical, Inc.|Anapharm Upang Matukoy ang Bioequivalence sa ilalim ng mga Kondisyon ng Pag-aayuno Enero 2000

Phase 1

NCT00648180 Mylan Pharmaceuticals Malusog Hulyo 2005

Phase 1

NCT01426269 Galderma Laboratories, LP Rosacea Setyembre 2011

Phase 4

NCT02753426 Unibersidad ng California, San Francisco Talamak na Sakit sa Bato|Cardiorenal Syndrome Abril 2016

Phase 1

NCT02583282 Postgraduate Institute ng Medikal na Edukasyon at Pananaliksik Malignant Pleural Effusion Agosto 1, 2015

Hindi maaari

NCT02927496 Ang Task Force for Global Health|United States Agency for International Development (USAID) Lymphedema|Lymphatic Filariasis|Filariasis Hunyo 19, 2018

Phase 3

NCT00652795 Par Pharmaceutical, Inc.|Anapharm Upang Matukoy ang Bioequivalence sa ilalim ng mga Kondisyon ng Pag-aayuno Hulyo 2004

Phase 1

NCT03956212 University Medical Center Ljubljana|University of Ljubljana School of Medicine, Slovenia Erythema Migrans Hunyo 1, 2017

Hindi maaari

NCT00855595 Bayer Papulopustular Rosacea Pebrero 2009

Phase 4

NCT03457636 Derm Research, PLLC Acne Marso 19, 2018

Phase 4

NCT02894268 Sir Run Run Shaw Hospital Impeksyon ng Helicobacter Pylori Pebrero 2016

Phase 4

NCT03465774 MD Anderson Cancer Center|National Cancer Institute (NCI) Malignant Pleural Effusion Marso 8, 2018

Maagang Phase 1

Kemikal na istraktura

Doxycycline-Hyclate

CERTIFICATE

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

KALIDAD NG PAMAMAHALA

Quality management1

Panukala18Mga proyekto sa Pagsusuri ng Pagkakaayon ng Kalidad na naaprubahan4, at6ang mga proyekto ay nasa ilalim ng pag-apruba.

Quality management2

Ang advanced na internasyonal na sistema ng pamamahala ng kalidad ay naglatag ng matatag na pundasyon para sa mga benta.

Quality management3

Ang pagsubaybay sa kalidad ay tumatakbo sa buong ikot ng buhay ng produkto upang matiyak ang kalidad at therapeutic effect.

Quality management4

Sinusuportahan ng pangkat ng Professional Regulatory Affairs ang mga hinihingi sa kalidad sa panahon ng aplikasyon at pagpaparehistro.

PAMAMAHALA SA PRODUKSYON

cpf5
cpf6

Korea Countec Bottled Packaging Line

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

KASAMA

Kooperasyong pandaigdig
International cooperation
Pakikipagtulungan sa tahanan
Domestic cooperation

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