drugset / Trial / NCT01134965

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

NCT01134965 ↗

Phase 1 Completed 24 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2010-06
Primary completion
2010-07
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified 0.5 mg —
Subject flibanserin Small molecule 100 mg —

Indications

No indication recorded.