Delving into the Latest Updates on Dabigatran etexilate tosylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

PAR-1 x thrombin

Action

antagonists, inhibitors

Mechanism

F2R antagonists(Protease-activated receptor-1 antagonists), thrombin inhibitors(Factor IIa inhibitors)

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Huons Co., Ltd.

Active Organization-

Inactive Organization

Huons Co., Ltd.

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor

The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran.

Start Date25 Sep 2024

Sponsor / Collaborator

International Bio Research

NCT05492318

/ CompletedPhase 1

Open-label, Single-center Study in Healthy Subjects to Investigate the Effect of Oral Givinostat on Pharmacokinetics (PK) of Intravenous and Oral Midazolam and Oral Dabigatran Etexilate (PART 1)

Primary objective:
1. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose pharmacokinetics (PK) of intravenous or oral midazolam.
2. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose PK of oral dabigatran etexilate.
Secondary objective:
To assess the safety and tolerability of concomitant administration of givinostat plus midazolam and dabigatran etexilate.

Start Date21 Mar 2022

Sponsor / Collaborator

Italfarmaco SpA

ChiCTR1900022313

/ RecruitingNot ApplicableIIT

A randomized controlled study for the effect of Rivaroxaban ,Warfarin,Dabigatran etexilate on the recurrence of non-valvularatrial fibrillation after catheterradio frequency ablation and mechanism exploration

Start Date02 Apr 2019

Sponsor / Collaborator