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Clinical Trials

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

Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS low
Drug: BIBR 1048 MS medium 1
Drug: BIBR 1048 MS medium 2
Drug: BIBR 1048 MS high
Drug: BIBR 1048 MS placebo

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02170831

Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS Capsule E
Drug: BIBR 1048 MS Capsule F
Drug: BIBR 1048 MS Capsule G
Drug: BIBR 1048 MS Tablet H
Drug: BIBR 1048 MS Drinking solution
Drug: Pantoprazole

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 15

Registration Number: NCT02170636

Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo to BIBR 1048 MS
Drug: BIBR 1048 MS dose 1
Drug: BIBR 1048 MS dose 2
Drug: BIBR 1048 MS dose 3
Drug: BIBR 1048 MS dose 4
Drug: BIBR 1048 MS dose 5

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02170116

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

Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate
Drug: Ketoconazole

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 24

Registration Number: NCT02170675

Tolerability of BIBR 953 ZW IV and Bioavailability of BIBR 1048 Tablet and Solution in Healthy Males

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS tablet
Drug: BIBR 953 ZW IV Placebo
Drug: BIBR 953 ZW IV
Drug: BIBR 1048 MS oral solution

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 30

Registration Number: NCT02170584

Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS Capsule I
Drug: BIBR 1048 MS Capsule K
Drug: Pantoprazole
Drug: BIBR 1048 MS drinking solution

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 12

Registration Number: NCT02170623

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate
Drug: Digoxin

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 24

Registration Number: NCT02171052

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

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