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Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

NCT01627665 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-10-09

No results posted yet for this study

Summary

The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Conditions

  • Healthy Volunteers

Interventions

DRUG

D->R->C+R

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

DRUG

D->R->C+D

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

DRUG

R->D->C+D

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

DRUG

R->D->C+R

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne Blanchard, MD · CIC HEGP

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • France

Study Locations

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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 NCT01627665 on ClinicalTrials.gov