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Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

NCT02127034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-07-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of steady state solifenacin and mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will also evaluate the safety and tolerability of the combined steady state administration of solifenacin, mirabegron and digoxin.

Conditions

  • Healthy Subjects
  • Pharmacokinetics
  • Drug-Drug Interaction (DDI)

Interventions

DRUG

Mirabegron

oral

DRUG

Solifenacin

oral

DRUG

Digoxin

oral

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Clinical Research Physician · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Germany

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 NCT02127034 on ClinicalTrials.gov