Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ticagrelor; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734772

1160.142

2012-002656-16 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects.

Exclusion criteria

1. Any relevant deviation from healthy conditions.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

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

Experimental group

Description:

multiple doses of dabigatran (alone)

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Test 1 (Part 1/Treatment B)

Experimental group

Description:

concomitant administration of dabigatran and ticagrelor

Treatment:

Drug: ticagrelor

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: ticagrelor

Drug: dabigatran etexilate

Drug: ticagrelor

Test 2 (Part 2/Treatment D)

Experimental group

Description:

staggered administration of ticagrelor and dabigatran

Treatment:

Drug: ticagrelor

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: ticagrelor

Drug: dabigatran etexilate

Drug: ticagrelor