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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134965
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : April 8, 2011
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Flibanserin plus Digoxin Drug: Digoxin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Digoxin plus Flibanserin
Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose
Drug: Flibanserin plus Digoxin
Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose

Experimental: Digoxin
Digoxin 0.5 mg as single dose
Drug: Digoxin
Digoxin 0.5 mg as single dose

Primary Outcome Measures :
  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 Outcome Measures :
  1. Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24) [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

healthy male and female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134965

511.158.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT01134965     History of Changes
Other Study ID Numbers: 511.158
2010-018950-11 ( EudraCT Number: EudraCT )
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs