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

Boehringer Ingelheim24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Flibanserin plus DigoxinDRUG

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

DigoxinDRUG

Digoxin 0.5 mg as single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: healthy male and female subjects

Locations (1)

511.158.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Maximum concentration of digoxin in plasma after single dose (Cmax)

Time frame: 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

Secondary Outcomes

Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24)

Time frame: 72 hours

Data from ClinicalTrials.gov

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