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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

NCT ID: NCT01734772

Last Updated: 2014-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

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To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference (Part 1/A, Part 2/C)

multiple doses of dabigatran (alone)

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

medium dose dabigatran

Test 1 (Part 1/Treatment B)

concomitant administration of dabigatran and ticagrelor

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

multiple doses of dabigatran

ticagrelor

Intervention Type DRUG

loading dose of ticagrelor

ticagrelor

Intervention Type DRUG

multiple doses of ticagrelor

Test 2 (Part 2/Treatment D)

staggered administration of ticagrelor and dabigatran

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

loading dose of ticagrelor

dabigatran etexilate

Intervention Type DRUG

single dose of dabigatran

Interventions

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dabigatran etexilate

multiple doses of dabigatran

Intervention Type DRUG

dabigatran etexilate

medium dose dabigatran

Intervention Type DRUG

ticagrelor

loading dose of ticagrelor

Intervention Type DRUG

ticagrelor

multiple doses of ticagrelor

Intervention Type DRUG

ticagrelor

loading dose of ticagrelor

Intervention Type DRUG

dabigatran etexilate

single dose of dabigatran

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male subjects.

Exclusion Criteria

1\. Any relevant deviation from healthy conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.142.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002656-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.142

Identifier Type: -

Identifier Source: org_study_id

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