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Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: D->R->C+R (Drug); D->R->C+D (Drug); R->D->C+D (Drug); R->D->C+R (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Anne Blanchard, MD, Principal Investigator, Affiliation: CIC HEGP

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.

Clinical Details

Official title: New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: AUC of plasma concentrations of the drugs

Secondary outcome: PKD of the drugs

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy participants

- Aged between 18-35 years inclusive

- Male

- Caucasian

- Body mass index (BMI) between 18 and 27 kg per m² inclusive.

Locations and Contacts

CIC Hopital europeen george pompidou, Paris 75015, France
Additional Information

Starting date: October 2011
Last updated: October 8, 2014

Page last updated: August 23, 2015

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