Dabigatran

Generic Name: Dabigatran

Brand Names: Dabigatran Etexilate Leon Farma, Dabigatran Etexilate Accord, Pradaxa

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₅N_₇O_₃

CAS Number: 211914-51-1

Unique Ingredient Identifier: I0VM4M70GC

Background: Dabigatran is the active form of the orally bioavailable prodrug dabigatran etexilate.

Clinical Trials

Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate polymorph II
Drug: Dabigatran etexilate polymorph I

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 66

Registration Number: NCT02171481

Bioavailability of Different Applications of Dabigatran in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate powder
Drug: Dabigatran etexilate capsule
Drug: Dabigatran etexilate pellets

First Posted Date: 2014-06-24

Last Posted Date: 2017-05-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 30

Registration Number: NCT02171611

Relative Bioavailability of Single Oral Doses of Dabigatran Etexilate With or Without Oral Administration of Verapamil in Two Different Dosages in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: dabigatran
Drug: Verapamil
Drug: Verapamil ER

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02171533

Investigation of the Impact of Concomitant Use of Multiple Doses of Clopidogrel With Multiple Doses of Dabigatran Etexilate on the Pharmacokinetic and Pharmacodynamic Parameters in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Clopidogrel
Drug: Dabigatran high dose
Drug: Dabigatran low dose

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 44

Registration Number: NCT02171598

Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS
Drug: Placebo of BIBR 1048 MS

First Posted Date: 2014-06-23

Last Posted Date: 2018-08-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02170844

Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS
Drug: Pantoprazole

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 18

Registration Number: NCT02170610

Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)
Drug: Dabigatran polymorph I

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 66

Registration Number: NCT02171013

Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 7

Registration Number: NCT02171000

Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Dabigatran etexilate low
Drug: Dabigatran etexilate high
Drug: Moxifloxacin

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02170987

Relative Bioavailability of Dabigatran and Atorvastatin in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran
Drug: Atorvastatin

First Posted Date: 2014-06-23

Last Posted Date: 2018-08-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 24

Registration Number: NCT02171039

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.