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Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

NCT02710630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-11-06

Study results available
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Summary

The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate.

The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate tablet E1

DRUG

Dabigatran etexilate tablet D1

DRUG

Dabigatran etexilate tablet C1

DRUG

Dabigatran etexilate tablet B1

DRUG

Dabigatran etexilate tablet A1

DRUG

Dabigatran etexilate capsule

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2016-05-11
Completion
2016-06-10

Countries

  • Japan

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 NCT02710630 on ClinicalTrials.gov