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Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers

NCT02171546 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-24

No results posted yet for this study

Summary

Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate,

Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate capsules

DRUG

Quinidine sulfate tablets

DRUG

Fexofenadine tablets

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-01-31

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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 NCT02171546 on ClinicalTrials.gov