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Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects

NCT02171455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-06-24

No results posted yet for this study

Summary

To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters prior to administration of a high dose of dabigatran etexilate in a QT study

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate low dose

DRUG

Dabigatran etexilate medium dose

DRUG

Dabigatran etexilate high dose

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-01-31

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Entities

Drugs
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 NCT02171455 on ClinicalTrials.gov