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OpenTrials
Completed

NCT Number: NCT01134965

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

511.158.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy male and female subjects

Treatment and study plan

Flibanserin plus Digoxin

Drug

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

Digoxin

Drug

Digoxin 0.5 mg as single dose

Primary outcomes

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

    Time frame: 72 hours

  2. 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

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

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
First posted
Jun 2, 2010
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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