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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01134965

Enrollment

Registered

2010-06-02

Start date

2010-06-30

Completion date

Unknown

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGFlibanserin plus Digoxin

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

DRUGDigoxin

Digoxin 0.5 mg as single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

healthy male and female subjects

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026