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
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