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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Flibanserin plus Digoxin; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134965

2010-018950-11 (EudraCT Number)

511.158

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

healthy male and female subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Digoxin plus Flibanserin

Experimental group

Description:

Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose

Treatment:

Drug: Flibanserin plus Digoxin

Digoxin

Experimental group

Description:

Digoxin 0.5 mg as single dose

Treatment:

Drug: Digoxin