Renewable Design for Hydrochlorothiazide 50 Mg - Dabigatran Etexilate Mesylate – CPF

Short Description:


Product Detail

Product Tags

Related Video

Feedback (2)

Well-run products, skilled income group, and better after-sales products and services; We have been also a unified massive family, all people stick with the business price "unification, dedication, tolerance" for Doxycycline Monohydrate Dosage, Folic Acid, Doxycycline Mono 50 Mg Cap Capsule, We warmly welcome clients from all around the world for almost any sort of cooperation with us to build a mutual advantage potential. We've been devoting ourselves wholeheartedly to supply consumers the very best company.
Renewable Design for Hydrochlorothiazide 50 Mg - Dabigatran Etexilate Mesylate – CPF Detail:

Description

Dabigatran etexilate mesylate (BIBR 1048MS) is an orally active prodrug of Dabigatran. Dabigatran etexilate mesylate has anticoagulant effects and is used for the prophylaxis of venousthromboembolism and stroke due to atrial fibrillation.

Background

Description: IC50 Value: 4.5nM (Ki); 10nM(Thrombin-induced platelet aggregation) [1] Dabigatran is a reversible and selective, direct thrombin inhibitor (DTI) undergoing advanced clinical development as its orally active prodrug,dabigatran etexilate. in vitro: Dabigatran selectively and reversibly inhibited human thrombin(Ki: 4.5 nM) as well as thrombin-induced platelet aggregation (IC(50): 10 nM), while showing no inhibitory effect on other platelet-stimulating agents.Thrombin generation in platelet-poor plasma (PPP), measured as the endogenous thrombin potential (ETP) was inhibited concentration-dependently (IC(50): 0.56 microM). Dabigatran demonstrated concentration-dependent anticoagulant effects in various species in vitro, doubling the activated partial thromboplastin time (aPTT), prothrombin time (PT) and ecarin clotting time (ECT) in human PPP at concentrations of 0.23, 0.83 and 0.18 microM, respectively [1]. in vivo: Dabigatran prolonged the aPTT dose-dependently after intravenous administration in rats (0.3, 1 and 3 mg/kg) and rhesus monkeys (0.15, 0.3 and 0.6 mg/kg). Dose- and time-dependent anticoagulant effects were observed with dabigatran etexilate administered orally to conscious rats (10, 20 and 50 mg/kg) or rhesus monkeys (1, 2.5 or 5 mg/kg), with maximum effects observed between 30 and 120 min after administration, respectively [1]. Patients treated with dabigatran etexilate experienced fewer ischaemic strokes (3.74 dabigatran etexilate vs 3.97 warfarin) and fewer combined intracranial haemorrhages and haemorrhagic strokes (0.43 dabigatran etexilate vs 0.99 warfarin) per 100 patient-years [2]. Clinical trial: An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients . Phase1

Storage

Powder

-20°C

3 years
 

4°C

2 years
In solvent

-80°C

6 months
 

-20°C

1 month

Clinical Trial

NCT Number Sponsor Condition Start Date

Phase

NCT02170792 Boehringer Ingelheim Healthy February 2001

Phase 1

NCT02170974 Boehringer Ingelheim Healthy July 2004

Phase 1

NCT02170831 Boehringer Ingelheim Healthy May 1999

Phase 1

NCT02170805 Boehringer Ingelheim Healthy April 2001

Phase 1

NCT02170610 Boehringer Ingelheim Healthy March 2002

Phase 1

NCT02170909 Boehringer Ingelheim Healthy December 2004

Phase 1

NCT02171000 Boehringer Ingelheim Healthy April 2005

Phase 1

NCT02170844 Boehringer Ingelheim Healthy June 2004

Phase 1

NCT02170584 Boehringer Ingelheim Healthy January 2001

Phase 1

NCT02170935 Boehringer Ingelheim Venous Thromboembolism April 2002

Phase 2

NCT02170636 Boehringer Ingelheim Healthy January 2002

Phase 1

NCT02170766 Boehringer Ingelheim Healthy October 2000

Phase 1

NCT02171442 Boehringer Ingelheim Healthy April 2002

Phase 1

NCT02170896 Boehringer Ingelheim Healthy October 2001

Phase 1

NCT02173730 Boehringer Ingelheim Healthy November 2002

Phase 1

NCT02170623 Boehringer Ingelheim Healthy February 2002

Phase 1

NCT02170116 Boehringer Ingelheim Healthy November 1998

Phase 1

NCT02170597 Boehringer Ingelheim Healthy August 2003

Phase 1

NCT01225822 Boehringer Ingelheim Venous Thromboembolism November 2002

Phase 2

NCT02170701 Boehringer Ingelheim Venous Thromboembolism October 2000

Phase 2

NCT02170740 Boehringer Ingelheim Healthy November 1999

Phase 1

NCT02170922 Boehringer Ingelheim Healthy July 1999

Phase 1

Chemical structure

Dabigatran Etexilate Mesylate

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

OUR STRENGTH

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.


VIEW MORE


VIEW MORE

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation


Product detail pictures:

Renewable Design for Hydrochlorothiazide 50 Mg - Dabigatran Etexilate Mesylate  – CPF detail pictures


Related Product Guide:

Our organization insists all along the quality policy of "product quality is base of business survival; purchaser gratification is the staring point and ending of an business; persistent improvement is eternal pursuit of staff" as well as the consistent purpose of "reputation 1st, purchaser first" for Renewable Design for Hydrochlorothiazide 50 Mg - Dabigatran Etexilate Mesylate – CPF , The product will supply to all over the world, such as: Curacao, Honduras, New York, Due to good quality and reasonable prices, our products have been exported to more than 10 countries and regions. We are looking forward to cooperating with all customers from at home and abroad. Moreover, customer satisfaction is our eternal pursuit.
  • The product classification is very detailed that can be very accurate to meet our demand, a professional wholesaler.
    5 Stars By Amy from Lisbon - 2018.09.21 11:44
    The accounts manager made a detailed introduction about the product, so that we have a comprehensive understanding of the product, and ultimately we decided to cooperate.
    5 Stars By ROGER Rivkin from New Zealand - 2017.10.27 12:12
    Write your message here and send it to us