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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Flibanserin plus Digoxin (Drug); Digoxin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf)

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


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion criteria: healthy male and female subjects

Locations and Contacts

511.158.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information

Starting date: June 2010
Last updated: April 7, 2011

Page last updated: August 23, 2015

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