MedTrace Logo

Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

NCT02044367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-05-20

Study results available
· View outcomes & findings →

Summary

To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate

Pellets (multiple dose of dabigatran)

DRUG

Dabigatran etexilate

Granules resolved in reconstitution solution (multiple dose of dabigatran)

DRUG

Dabigatran etexilate

Hard capsule (multiple dose of dabigatran)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044367 on ClinicalTrials.gov