to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

April 7, 2011 updated by: Boehringer Ingelheim

An Open Two-way Cross-over Study to Evaluate the Effect of Multiple Doses of Flibanserin 100 mg Film-coated Tablets Given Once Daily on the Single Dose Pharmacokinetics of Digoxin 0.5 mg in Healthy Male and Female Volunteers

The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. Flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Biberach, Germany
        • 511.158.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

healthy male and female subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digoxin plus Flibanserin
Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose
Drug: Flibanserin plus Digoxin
Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose
Experimental: Digoxin
Digoxin 0.5 mg as single dose
Drug: Digoxin
Digoxin 0.5 mg as single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration of digoxin in plasma after single dose (Cmax)
Time Frame: 72 hours
72 hours
Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24)
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.158
  • 2010-018950-11 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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