Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers

NCT02171481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-06-24

No results posted yet for this study

Summary

To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate polymorph II

DRUG

Dabigatran etexilate polymorph I

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-08-31

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Entities

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 NCT02171481 on ClinicalTrials.gov