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

NCT ID: NCT01134965

Last Updated: 2011-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Flibanserin plus Digoxin

Intervention Type DRUG

Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose

Digoxin

Digoxin 0.5 mg as single dose

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Digoxin 0.5 mg as single dose

Interventions

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Flibanserin plus Digoxin

Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose

Intervention Type DRUG

Digoxin

Digoxin 0.5 mg as single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy male and female subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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511.158.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018950-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

511.158

Identifier Type: -

Identifier Source: org_study_id

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